{"id":"fluticasone-furoate","rwe":[{"pmid":"41817036","year":"2026","title":"Critical evaluation of fluticasone furoate/umeclidinium/vilanterol in asthma cough management: Insights and limitations from the COCOA study.","finding":"","journal":"The Journal of asthma : official journal of the Association for the Care of Asthma","studyType":"Clinical Study"},{"pmid":"41801200","year":"2026","title":"Fluticasone- vs Budesonide-Based Dual Therapy for COPD.","finding":"","journal":"JAMA network open","studyType":"Clinical Study"},{"pmid":"41753185","year":"2026","title":"Is Clinical Remission, an Ambitious Treatment Goal, Achievable in Patients with Moderate-to-Severe Asthma on Inhaled Therapies: How Ambitious Should We Be?","finding":"","journal":"Journal of clinical medicine","studyType":"Clinical Study"},{"pmid":"41679900","year":"2026","title":"Economic evaluation of single-inhaler triple therapy for chronic obstructive pulmonary disease in Thailand.","finding":"","journal":"BMJ open respiratory research","studyType":"Clinical Study"},{"pmid":"41673353","year":"2026","title":"A Pragmatic RCT of FF/UMEC/VI in Patients with Uncontrolled Asthma: PERFORM Protocol.","finding":"","journal":"Pulmonary therapy","studyType":"Clinical Study"}],"_fda":{"id":"85fd731d-433f-4eba-aad8-6eda4550138e","set_id":"107100af-7ca2-44e8-b067-c0ab0a19a6dc","openfda":{"unii":["JS86977WNV"],"route":["NASAL"],"rxcui":["1797890","1869712"],"spl_id":["85fd731d-433f-4eba-aad8-6eda4550138e"],"brand_name":["FLONASE SENSIMIST ALLERGY RELIEF"],"spl_set_id":["107100af-7ca2-44e8-b067-c0ab0a19a6dc"],"package_ndc":["0135-0615-01","0135-0615-02","0135-0615-03","0135-0615-04","0135-0615-05","0135-0615-06"],"product_ndc":["0135-0615"],"generic_name":["FLUTICASONE FUROATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["FLUTICASONE FUROATE"],"manufacturer_name":["Haleon US Holdings LLC"],"application_number":["NDA022051"],"is_original_packager":[true]},"purpose":["Purpose Allergy symptom reliever"],"version":"11","stop_use":["Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds"],"warnings":["Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"questions":["Questions or comments? call toll-free 1-844-FLONASE (1-844-356-6273)"],"ask_doctor":["Ask a doctor before use if you have or had glaucoma or cataracts"],"do_not_use":["Do not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients"],"when_using":["When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one"],"effective_time":"20241219","active_ingredient":["Active ingredient (in each spray) Fluticasone furoate 27.5 mcg (glucocorticoid)* *read the Question & Answer Book"],"inactive_ingredient":["Inactive ingredients benzalkonium chloride solution, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium, microcrystalline cellulose, polysorbate 80, purified water"],"storage_and_handling":["Other information • you may start to feel relief the first day and full effect after several days of regular, once-a-day use • store between 15° – 30°C (59° – 86°F) • do not refrigerate or freeze • keep this label and enclosed materials. They contain important additional information."],"indications_and_usage":["Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes (for ages 12 and older)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection)"],"spl_unclassified_section":["Generic Section FLONASE SENSIMIST ALLERGY RELIEF What problems can FLONASE SENSIMIST Allergy Relief help with? FLONASE SENSIMIST Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes*. Nasal symptoms Eye symptoms* *for ages 12 and older. These symptoms can be triggered by allergens like pollen, mold, dust or pet dander. Outdoor allergens Animal allergens Indoor allergens IMPORTANT – Peel here for complete Drug Facts label. Children 2-11: do not use for more than 2 months a year. Be sure to read the Quick Start Guide and Question & Answer Book inside package TAMPER-EVIDENT features for your protection. The product is packaged in a sealed plastic container. The bottle is housed within a plastic dispenser that prevents direct access to the bottle. Do not use if the container or any part of the plastic dispenser, including the dispenser bottom, is damaged or broken."],"dosage_and_administration":["Directions • read the Quick Start Guide for how to: • shake vigorously before each use • prime the bottle • use the spray • sniff gently after each spray • clean the spray nozzle with a clean dry tissue • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1 – use 2 sprays in each nostril once daily • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 2 TO 11 YEARS OF AGE • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once daily CHILDREN UNDER 2 YEARS OF AGE • do not use"],"spl_product_data_elements":["FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate FLUTICASONE FUROATE FLUTICASONE BENZALKONIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS DEXTROSE EDETATE DISODIUM MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 WATER"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["Principal Display Panel FLONASE SENSIMIST ALLERGY RELIEF Fluticasone Furoate Nasal Spray 27.5 mcg Per Spray Allergy Symptom Reliever (Glucocorticoid)* Non-Drowsy Relief of: • Nasal congestion • itchy, watery eyes • Itchy nose • Runny nose • Sneezing FULL PRESCRIPTION STRENGTH 24 HOUR RELIEF 120 METERED SPRAYS *Fluticasone furoate is a steroid medicine known as a glucocorticoid. 0.31 fl oz (9.1 mL) Flonase Sensimist 120 sprays"]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"PGR","category":"gene"},{"label":"NR3C2","category":"gene"},{"label":"D07AC17","category":"atc"},{"label":"Respiratory (Inhalation)","category":"route"},{"label":"Nasal","category":"route"},{"label":"Powder","category":"form"},{"label":"Spray","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Asthma","category":"indication"},{"label":"Chronic Non-Allergic Rhinitis","category":"indication"},{"label":"Chronic bronchitis","category":"indication"},{"label":"Chronic obstructive lung disease","category":"indication"},{"label":"Pulmonary emphysema","category":"indication"},{"label":"Haleon Us Holdings","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Bronchodilator Agents","category":"pharmacology"},{"label":"Dermatologic Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"12215 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"8743 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"6457 reports"},{"date":"","signal":"ASTHMA","source":"FDA FAERS","actionTaken":"6290 reports"},{"date":"","signal":"WRONG TECHNIQUE IN DEVICE USAGE PROCESS","source":"FDA FAERS","actionTaken":"5573 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"4869 reports"},{"date":"","signal":"PRODUCT COMPLAINT","source":"FDA FAERS","actionTaken":"4839 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"4267 reports"},{"date":"","signal":"WHEEZING","source":"FDA FAERS","actionTaken":"4017 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"3412 reports"}],"commonSideEffects":[{"effect":"Upper respiratory tract infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Pneumonia","drugRate":"","severity":"common","organSystem":""},{"effect":"Bronchitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Oral candidiasis","drugRate":"","severity":"common","organSystem":""},{"effect":"Arthralgia","drugRate":"","severity":"common","organSystem":""},{"effect":"Influenza","drugRate":"","severity":"common","organSystem":""},{"effect":"Sinusitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Pharyngitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Rhinitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"","severity":"common","organSystem":""},{"effect":"Urinary tract infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Dysphonia","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Back pain","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Dysgeusia","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Oropharyngeal pain","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Gastroenteritis","drugRate":"1%","severity":"common","organSystem":""}],"contraindications":["Adrenal cortical hypofunction","Bacterial infectious disease","Bilateral cataracts","Disease caused by parasite","Epistaxis","Exposure to varicella","Glaucoma","Hypercortisolism","Measles","Mycosis","Nasal Candidiasis","Nasal Septal Ulcers","Nasal Trauma","Ocular hypertension","Operation on nose","Ophthalmic herpes simplex","Perforation of nasal septum","Pulmonary tuberculosis","Varicella-zoster virus infection","Viral disease"],"specialPopulations":{"Pregnancy":"There are insufficient data on the use of ARNUITY ELLIPTA in pregnant women. There are clinical considerations with use of ARNUITY ELLIPTA in pregnant women to inform drug-associated risk. (See Clinical Considerations.) In animal reproduction studies, fluticasone furoate administered by inhalation to rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. The highest fluticasone furoate doses in the rat and rabbit studies were times and times the maximum recommended human daily inhalation dose (MRHDID), respectively. (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.Clinical ConsiderationsDisease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma.","Geriatric use":"Clinical studies of VERAMYST Nasal Spray did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy in the elderly.","Paediatric use":"Controlled clinical trials with VERAMYST Nasal Spray included 1,224 patients aged to 11 years and 344 adolescent patients aged 12 to 17 years [see Clinical Studies (14)]. The safety and effectiveness of VERAMYST Nasal Spray in children younger than years have not been established.Controlled clinical studies have shown that intranasal corticosteroids may cause reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence","Hepatic impairment":"Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects."},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Haleon Us Holdings","patents":[{"applNo":"N022051","source":"FDA Orange Book","status":"Active","expires":"Jul 15, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8347879","drugSubstance":false},{"applNo":"N022051","source":"FDA Orange Book","status":"Active","expires":"Apr 5, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8062264","drugSubstance":false},{"applNo":"N022051","source":"FDA Orange Book","status":"Active","expires":"Oct 15, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8147461","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FLUTICASONE FUROATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:18:20.991073+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:18:20.990986+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:18:55.737219+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:18:26.753673+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:18:21.062644+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:18:19.902695+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUTICASONE FUROATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:18:27.092237+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:18:16.490487+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:18:49.510638+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:18:16.490509+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:18:28.649009+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:18:28.172008+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1676/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:18:27.833780+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA022051","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:18:16.490512+00:00"}},"allNames":"arnuity ellipta","offLabel":[],"synonyms":["fluticasone furoate","avamys","veramyst"],"timeline":[{"date":"2007-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from GLAXOSMITHKLINE to Haleon Us Holdings"},{"date":"2007-04-27","type":"positive","source":"DrugCentral","milestone":"FDA approval (Glaxosmithkline)"},{"date":"2008-01-11","type":"positive","source":"DrugCentral","milestone":"EMA approval (GlaxoSmithKline (Ireland) Limited)"},{"date":"2009-04-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (GlaxoSmithKline K.K.)"},{"date":"2014-08-20","type":"positive","source":"FDA Orange Book","milestone":"Arnuity Ellipta approved — 0.1MG/INH"}],"aiSummary":"Fluticasone Furoate (Arnuity Ellipta), marketed by Haleon US Holdings, is a glucocorticoid receptor agonist primarily indicated for nasal congestion relief. Its key strength lies in its mechanism of action, which effectively reduces inflammation and swelling in the airways, positioning it as a strong competitor in the market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","approvals":[{"date":"2007-04-27","orphan":false,"company":"GLAXOSMITHKLINE","regulator":"FDA"},{"date":"2008-01-11","orphan":false,"company":"GlaxoSmithKline (Ireland) Limited","regulator":"EMA"},{"date":"2009-04-22","orphan":false,"company":"GlaxoSmithKline K.K.","regulator":"PMDA"}],"brandName":"Arnuity Ellipta","ecosystem":[{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Asthma","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"}],"globalPrevalence":262000000},{"indication":"Chronic Non-Allergic Rhinitis","otherDrugs":[{"name":"budesonide","slug":"budesonide","company":""},{"name":"desonide","slug":"desonide","company":"Perrigo New York"},{"name":"flunisolide","slug":"flunisolide","company":""},{"name":"fluticasone propionate","slug":"fluticasone-propionate","company":"Fougera Pharms"}],"globalPrevalence":null},{"indication":"Chronic bronchitis","otherDrugs":[{"name":"arformoterol","slug":"arformoterol","company":"Sunovion"},{"name":"diprophylline","slug":"diprophylline","company":""},{"name":"tiotropium bromide","slug":"tiotropium-bromide","company":"Boehringer Ingelheim"},{"name":"umeclidinium","slug":"umeclidinium","company":"Glaxosmithkline"}],"globalPrevalence":null},{"indication":"Chronic obstructive lung disease","otherDrugs":[{"name":"aclidinium bromide","slug":"aclidinium-bromide","company":"Astrazeneca Pharms"},{"name":"arformoterol","slug":"arformoterol","company":"Sunovion"},{"name":"glycopyrronium bromide","slug":"glycopyrronium-bromide","company":"Shionogi Inc"},{"name":"ipratropium","slug":"ipratropium","company":""}],"globalPrevalence":null},{"indication":"Pulmonary emphysema","otherDrugs":[{"name":"arformoterol","slug":"arformoterol","company":"Sunovion"},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"},{"name":"diprophylline","slug":"diprophylline","company":""},{"name":"epinephrine","slug":"epinephrine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"},{"gene":"PGR","source":"DrugCentral","target":"Progesterone receptor","protein":"Progesterone receptor"},{"gene":"NR3C2","source":"DrugCentral","target":"Mineralocorticoid receptor","protein":"Mineralocorticoid receptor"}],"moaClass":"Corticosteroid Hormone Receptor Agonists","modality":"Small Molecule","drugClass":"Corticosteroid","explanation":"","oneSentence":"","technicalDetail":"Arnuity Ellipta is a corticosteroid that exerts its effects by binding to the glucocorticoid receptor (GR), a transcription factor that regulates the expression of anti-inflammatory genes, thereby reducing inflammation and airway hyperresponsiveness."},"commercial":{"launchDate":"2007","revenueYear":2024,"_launchSource":"DrugCentral (FDA 2007-04-27, GLAXOSMITHKLINE)","annualRevenue":3100,"revenueSource":"Verified: GSK AR","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4554","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FLUTICASONE%20FUROATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUTICASONE FUROATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T11:34:24.436263","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T01:18:55.737314+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"betamethasone","drugSlug":"betamethasone","fdaApproval":"1961-04-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"desoximetasone","drugSlug":"desoximetasone","fdaApproval":"1977-02-28","patentExpiry":"Sep 1, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fluocinolone acetonide","drugSlug":"fluocinolone-acetonide","fdaApproval":"1963-02-15","patentExpiry":"Nov 7, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fludroxycortide","drugSlug":"fludroxycortide","fdaApproval":"1963-03-19","relationship":"same-class"},{"drugName":"fluocinonide","drugSlug":"fluocinonide","fdaApproval":"1971-06-30","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"budesonide","drugSlug":"budesonide","fdaApproval":"1994-02-14","patentExpiry":"Sep 9, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"diflorasone diacetate","drugSlug":"diflorasone-diacetate","fdaApproval":"1977-09-14","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amcinonide","drugSlug":"amcinonide","fdaApproval":"1979-10-18","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"mometasone furoate","drugSlug":"mometasone-furoate","fdaApproval":"1987-04-30","patentExpiry":"Oct 3, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-class"},{"drugName":"hydrocortisone aceponate","drugSlug":"hydrocortisone-aceponate","fdaApproval":"","relationship":"same-class"},{"drugName":"fluticasone propionate","drugSlug":"fluticasone-propionate","fdaApproval":"1990-12-14","patentExpiry":"Sep 26, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prednicarbate","drugSlug":"prednicarbate","fdaApproval":"1991-09-23","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"difluprednate","drugSlug":"difluprednate","fdaApproval":"2008-06-23","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ulobetasol propionate","drugSlug":"ulobetasol-propionate","fdaApproval":"1990-12-17","relationship":"same-class"}],"genericName":"fluticasone furoate","indications":{"approved":[{"id":"fluticasone-furoate-nasal-congestion-relief","name":"Nasal Congestion Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Ages 12 and older","pivotalTrial":null,"restrictions":[],"patientPopulation":"Ages 12 and older","diagnosticRequired":null,"brandNameForIndication":"Arnuity Ellipta"},{"id":"fluticasone-furoate-runny-nose-relief","name":"Runny Nose Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Ages 12 and older","pivotalTrial":null,"restrictions":[],"patientPopulation":"Ages 12 and older","diagnosticRequired":null,"brandNameForIndication":"Arnuity Ellipta"},{"id":"fluticasone-furoate-sneezing-relief","name":"Sneezing Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Ages 12 and older","pivotalTrial":null,"restrictions":[],"patientPopulation":"Ages 12 and older","diagnosticRequired":null,"brandNameForIndication":"Arnuity Ellipta"},{"id":"fluticasone-furoate-itchy-nose-relief","name":"Itchy Nose Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Ages 12 and older","pivotalTrial":null,"restrictions":[],"patientPopulation":"Ages 12 and older","diagnosticRequired":null,"brandNameForIndication":"Arnuity Ellipta"},{"id":"fluticasone-furoate-itchy,-watery-eyes-relief","name":"Itchy, Watery Eyes Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Ages 12 and older","pivotalTrial":null,"restrictions":[],"patientPopulation":"Ages 12 and older","diagnosticRequired":null,"brandNameForIndication":"Arnuity Ellipta"}],"offLabel":[],"pipeline":[]},"currentOwner":"Haleon Us Holdings","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"betamethasone","brandName":"betamethasone","genericName":"betamethasone","approvalYear":"1961","relationship":"same-class"},{"drugId":"desoximetasone","brandName":"desoximetasone","genericName":"desoximetasone","approvalYear":"1977","relationship":"same-class"},{"drugId":"fluocinolone-acetonide","brandName":"fluocinolone acetonide","genericName":"fluocinolone acetonide","approvalYear":"1963","relationship":"same-class"},{"drugId":"fludroxycortide","brandName":"fludroxycortide","genericName":"fludroxycortide","approvalYear":"1963","relationship":"same-class"},{"drugId":"fluocinonide","brandName":"fluocinonide","genericName":"fluocinonide","approvalYear":"1971","relationship":"same-class"},{"drugId":"budesonide","brandName":"budesonide","genericName":"budesonide","approvalYear":"1994","relationship":"same-class"},{"drugId":"diflorasone-diacetate","brandName":"diflorasone diacetate","genericName":"diflorasone diacetate","approvalYear":"1977","relationship":"same-class"},{"drugId":"amcinonide","brandName":"amcinonide","genericName":"amcinonide","approvalYear":"1979","relationship":"same-class"},{"drugId":"mometasone-furoate","brandName":"mometasone furoate","genericName":"mometasone furoate","approvalYear":"1987","relationship":"same-class"},{"drugId":"beclometasone-dipropionate","brandName":"beclometasone dipropionate","genericName":"beclometasone dipropionate","approvalYear":"1976","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06052267","phase":"PHASE3","title":"A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations","status":"RECRUITING","sponsor":"Teva Branded Pharmaceutical Products R&D LLC","startDate":"2023-08-30","conditions":["Asthma"],"enrollment":2700,"completionDate":"2026-10-31"},{"nctId":"NCT06372496","phase":"PHASE4","title":"Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2024-04-16","conditions":["Asthma"],"enrollment":1366,"completionDate":"2027-03-31"},{"nctId":"NCT06676319","phase":"PHASE2","title":"Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-11-07","conditions":["Asthma"],"enrollment":1147,"completionDate":"2027-10-15"},{"nctId":"NCT06850805","phase":"PHASE3","title":"Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps","status":"RECRUITING","sponsor":"Optinose US Inc.","startDate":"2025-07-28","conditions":["Chronic Rhinosinusitis Without Nasal Polyps"],"enrollment":84,"completionDate":"2028-10-31"},{"nctId":"NCT05608681","phase":"PHASE1,PHASE2","title":"A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).","status":"RECRUITING","sponsor":"Eupraxia Pharmaceuticals Inc.","startDate":"2023-03-31","conditions":["Eosinophilic Esophagitis"],"enrollment":117,"completionDate":"2026-12"},{"nctId":"NCT06664619","phase":"PHASE3","title":"A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma","status":"RECRUITING","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2024-12-12","conditions":["Asthma"],"enrollment":724,"completionDate":"2026-05-31"},{"nctId":"NCT05309590","phase":"","title":"Efficacy of Low-Dose Topical Steroids in Maintaining Remission of Eosinophilic Esophagitis in Children","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2014-05","conditions":["Eosinophilic Esophagitis"],"enrollment":50,"completionDate":"2027-11"},{"nctId":"NCT05275686","phase":"PHASE2","title":"Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)","status":"RECRUITING","sponsor":"Cedars-Sinai Medical Center","startDate":"2022-04-20","conditions":["Eustachian Tube Dysfunction"],"enrollment":80,"completionDate":"2027-12-31"},{"nctId":"NCT02476825","phase":"PHASE4","title":"A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospitals, Leicester","startDate":"2016-01-20","conditions":["Healthy"],"enrollment":30,"completionDate":"2026-10-31"},{"nctId":"NCT03742414","phase":"PHASE2","title":"Seal, Stopping Eczema and Allergy Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kari Nadeau, MD, PhD","startDate":"2021-06-30","conditions":["Eczema, Infantile","Eczema","Atopic Dermatitis Eczema","Atopic Dermatitis"],"enrollment":398,"completionDate":"2028-06-30"},{"nctId":"NCT07415278","phase":"PHASE4","title":"INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pamukkale University","startDate":"2022-12-01","conditions":["Allergic Rhinitis"],"enrollment":61,"completionDate":"2026-10-30"},{"nctId":"NCT07282886","phase":"PHASE2","title":"VENTURI (VENTilation Using Respiratory Imaging)","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-03-15","conditions":["Asthma"],"enrollment":20,"completionDate":"2030-12-31"},{"nctId":"NCT05922761","phase":"PHASE2","title":"BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)","status":"RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2024-05-31","conditions":["Bronchiolitis Obliterans Syndrome","Bronchiolitis Obliterans","Lung Diseases","Chronic Graft Versus Host Disease"],"enrollment":45,"completionDate":"2027-12-31"},{"nctId":"NCT07396987","phase":"NA","title":"Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation","status":"NOT_YET_RECRUITING","sponsor":"Juan Carlos Cardet","startDate":"2026-02","conditions":["Asthma Attack","Asthma Control","Asthma Exacerbations","Asthma"],"enrollment":40,"completionDate":"2027-04"},{"nctId":"NCT07223294","phase":"PHASE3","title":"Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma","status":"NOT_YET_RECRUITING","sponsor":"Sandoz","startDate":"2026-04","conditions":["Respiratory"],"enrollment":1430,"completionDate":"2026-10-31"},{"nctId":"NCT05776927","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","status":"NOT_YET_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-05-29","conditions":["Asthma"],"enrollment":304,"completionDate":"2029-12-24"},{"nctId":"NCT06572228","phase":"PHASE4","title":"Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma","status":"RECRUITING","sponsor":"Regeneron Pharmaceuticals","startDate":"2024-08-26","conditions":["Asthma"],"enrollment":250,"completionDate":"2026-12-31"},{"nctId":"NCT06905483","phase":"PHASE4","title":"Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study","status":"COMPLETED","sponsor":"Thammasat University","startDate":"2025-04-01","conditions":["COPD","Chronic Obstructive Pulmonary Disease (COPD)","Small Airway Disease","Triple Therapy","Lung Function"],"enrollment":22,"completionDate":"2026-01-28"},{"nctId":"NCT07380178","phase":"NA","title":"The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis","status":"COMPLETED","sponsor":"Universitas Sebelas Maret","startDate":"2025-04-01","conditions":["Rhinitis, Allergic, Perennial"],"enrollment":40,"completionDate":"2025-07-05"},{"nctId":"NCT07329946","phase":"NA","title":"Immuno-inflammatory Response of Erdosteine in COPD","status":"NOT_YET_RECRUITING","sponsor":"Pierachille Santus, MD, PhD","startDate":"2026-02-28","conditions":["COPD"],"enrollment":30,"completionDate":"2027-12-31"},{"nctId":"NCT07324707","phase":"PHASE2","title":"Study on the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma","status":"RECRUITING","sponsor":"Anhui Palo Alto Pharmaceuticals, Inc.","startDate":"2025-10-15","conditions":["Bronchial Asthma"],"enrollment":30,"completionDate":"2026-03"},{"nctId":"NCT07318350","phase":"PHASE3","title":"Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA)","status":"NOT_YET_RECRUITING","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-10","conditions":["Moderate Asthma"],"enrollment":174,"completionDate":"2028-09"},{"nctId":"NCT07315555","phase":"NA","title":"Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma","status":"NOT_YET_RECRUITING","sponsor":"Tanta University","startDate":"2026-01-01","conditions":["Community Acquired Pneumonia"],"enrollment":90,"completionDate":"2026-10-31"},{"nctId":"NCT07294326","phase":"PHASE4","title":"A Prospective, Randomized, Controlled Study Comparing the Efficacy of Intranasal Corticosteroids (INCS) Combined With Intranasal Antihistamines (INAH) and INCS Combined With Oral Antihistamines (OAH) in the Treatment of Moderate to Severe Allergic Rhinitis Symptoms","status":"NOT_YET_RECRUITING","sponsor":"China-Japan Union Hospital","startDate":"2026-01-01","conditions":["Allergic Rhinitis"],"enrollment":50,"completionDate":"2026-11-01"},{"nctId":"NCT05735431","phase":"PHASE3","title":"Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil","status":"WITHDRAWN","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-06","conditions":["Moderate Asthma"],"enrollment":0,"completionDate":"2027-11"},{"nctId":"NCT05535972","phase":"PHASE4","title":"To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-10-14","conditions":["Pulmonary Disease, Chronic Obstructive"],"enrollment":463,"completionDate":"2023-09-25"},{"nctId":"NCT05292053","phase":"PHASE4","title":"Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations","status":"COMPLETED","sponsor":"Baylor Research Institute","startDate":"2022-07-01","conditions":["Copd"],"enrollment":80,"completionDate":"2025-02-09"},{"nctId":"NCT05299086","phase":"PHASE3","title":"As Needed Versus Regular Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis","status":"COMPLETED","sponsor":"Mahidol University","startDate":"2022-04-04","conditions":["Perennial Allergic Rhinitis","Child, Only"],"enrollment":68,"completionDate":"2025-04-30"},{"nctId":"NCT04885530","phase":"PHASE3","title":"ACTIV-6: COVID-19 Study of Repurposed Medications","status":"COMPLETED","sponsor":"Susanna Naggie, MD","startDate":"2021-06-08","conditions":["Covid19"],"enrollment":10956,"completionDate":"2024-04-29"},{"nctId":"NCT05535738","phase":"PHASE2,PHASE3","title":"Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation","status":"RECRUITING","sponsor":"Wei-Che Ko","startDate":"2022-11-15","conditions":["Skin Inflammation","Allergic Contact Dermatitis"],"enrollment":45,"completionDate":"2027-12-31"},{"nctId":"NCT07052942","phase":"PHASE4","title":"Individualizing Treatment for Asthma in Primary Care (Full Study)","status":"RECRUITING","sponsor":"DARTNet Institute","startDate":"2025-08-01","conditions":["Asthma","Asthma Attack","Asthma Exacerbations"],"enrollment":3200,"completionDate":"2029-11-15"},{"nctId":"NCT05757102","phase":"PHASE3","title":"A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2023-04-25","conditions":["Asthma"],"enrollment":292,"completionDate":"2027-01-15"},{"nctId":"NCT05095116","phase":"","title":"Expanded Access Protocol for Patients With Eosinophilic Esophagitis","status":"NO_LONGER_AVAILABLE","sponsor":"Ellodi Pharmaceuticals, LP","startDate":"","conditions":["Eosinophilic Esophagitis"],"enrollment":0,"completionDate":""},{"nctId":"NCT07192016","phase":"PHASE4","title":"129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation","status":"NOT_YET_RECRUITING","sponsor":"Western University, Canada","startDate":"2026-03","conditions":["Chronic Obstructive Pulmonary Disease (COPD)"],"enrollment":60,"completionDate":"2027-10"},{"nctId":"NCT06040268","phase":"PHASE1,PHASE2","title":"Advair HFA in Healthy and HAPE Predisposed Subjects","status":"RECRUITING","sponsor":"University of Colorado, Denver","startDate":"2023-12-12","conditions":["Altitude Edema"],"enrollment":60,"completionDate":"2026-12-15"},{"nctId":"NCT04655508","phase":"PHASE3","title":"Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-05-21","conditions":["Stem Cell Transplant Complications","Respiratory Disease","Bronchiolitis Obliterans"],"enrollment":35,"completionDate":"2023-09-27"},{"nctId":"NCT06858137","phase":"NA","title":"Thread Embedding Acupuncture For Rhinitis Allergy","status":"COMPLETED","sponsor":"University of Medicine and Pharmacy at Ho Chi Minh City","startDate":"2024-12-15","conditions":["Rhinitis Allergic"],"enrollment":64,"completionDate":"2025-07-31"},{"nctId":"NCT04651777","phase":"PHASE3","title":"Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Dr. Grace Parraga","startDate":"2022-08-08","conditions":["Asthma"],"enrollment":31,"completionDate":"2025-12"},{"nctId":"NCT06290102","phase":"PHASE1","title":"Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2024-05-16","conditions":["Asthma"],"enrollment":30,"completionDate":"2024-10-07"},{"nctId":"NCT05634746","phase":"PHASE3","title":"24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)","status":"COMPLETED","sponsor":"Ellodi Pharmaceuticals, LP","startDate":"2022-12-29","conditions":["Eosinophilic Esophagitis"],"enrollment":218,"completionDate":"2024-08-12"},{"nctId":"NCT05457855","phase":"","title":"Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2022-02-01","conditions":["Asthma"],"enrollment":51533,"completionDate":"2023-12-31"},{"nctId":"NCT04937387","phase":"PHASE3","title":"Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-07-29","conditions":["Asthma"],"enrollment":359,"completionDate":"2024-08-05"},{"nctId":"NCT07114107","phase":"NA","title":"Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-08","conditions":["Atopic Rhinitis","Atopic Asthma"],"enrollment":200,"completionDate":"2026-05"},{"nctId":"NCT04480242","phase":"","title":"Asthma Research in Children and Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Parc de Salut Mar","startDate":"2017-07-26","conditions":["Persistent Asthma","Asthma in Children","Asthma Exacerbation"],"enrollment":525,"completionDate":"2030-12-31"},{"nctId":"NCT07058259","phase":"NA","title":"Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD","status":"ACTIVE_NOT_RECRUITING","sponsor":"Istanbul Medeniyet University","startDate":"2024-11-15","conditions":["COPD (Chronic Obstructive Pulmonary Disease)","Acupuncture"],"enrollment":60,"completionDate":"2026-01-15"},{"nctId":"NCT03248128","phase":"PHASE3","title":"Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-10-20","conditions":["Asthma"],"enrollment":906,"completionDate":"2022-03-21"},{"nctId":"NCT05545072","phase":"PHASE3","title":"Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)","status":"TERMINATED","sponsor":"Emory University","startDate":"2023-10-26","conditions":["Allergic Fungal Rhinosinusitis"],"enrollment":5,"completionDate":"2024-07-10"},{"nctId":"NCT06474039","phase":"PHASE3","title":"The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD","status":"RECRUITING","sponsor":"Mahidol University","startDate":"2024-10-01","conditions":["COPD"],"enrollment":50,"completionDate":"2026-12"},{"nctId":"NCT05706636","phase":"NA","title":"T Central Memory Cells in Early Localized Non-Segmental Vitiligo","status":"COMPLETED","sponsor":"Cairo University","startDate":"2023-02-01","conditions":["Vitiligo"],"enrollment":22,"completionDate":"2025-04-15"},{"nctId":"NCT06272370","phase":"PHASE4","title":"Individualizing Treatment for Asthma in Primary Care","status":"COMPLETED","sponsor":"DARTNet Institute","startDate":"2024-02-01","conditions":["Asthma","Bronchial Diseases","Respiratory Tract Infections","Lung Diseases, Obstructive","Lung Diseases","Respiratory Hypersensitivity","Immune System Diseases"],"enrollment":103,"completionDate":"2024-12-31"},{"nctId":"NCT06066606","phase":"NA","title":"U-LABA/ICS Effects on Exercise Performance, Vilanterol","status":"RECRUITING","sponsor":"Morten Hostrup, PhD","startDate":"2023-10-03","conditions":["Exercise Performance"],"enrollment":30,"completionDate":"2026-12-01"},{"nctId":"NCT06077019","phase":"NA","title":"Role of Lung Function for Exercise Capacity in Well-trained Individuals","status":"RECRUITING","sponsor":"Morten Hostrup, PhD","startDate":"2023-10-03","conditions":["Exercise Performance"],"enrollment":60,"completionDate":"2026-12-01"},{"nctId":"NCT01202097","phase":"PHASE3","title":"A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with Asthma","status":"COMPLETED","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2011-08","conditions":["Asthma"],"enrollment":334,"completionDate":"2012-05"},{"nctId":"NCT06552364","phase":"PHASE4","title":"Air Pollution and Inhaled Corticosteroids in COPD","status":"NOT_YET_RECRUITING","sponsor":"University of British Columbia","startDate":"2025-04-01","conditions":["COPD"],"enrollment":48,"completionDate":"2028-12-31"},{"nctId":"NCT04923347","phase":"PHASE4","title":"A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-06-06","conditions":["Pulmonary Disease, Chronic Obstructive"],"enrollment":229,"completionDate":"2024-03-14"},{"nctId":"NCT03141424","phase":"PHASE4","title":"Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma","status":"COMPLETED","sponsor":"Hvidovre University Hospital","startDate":"2022-06-01","conditions":["Asthma"],"enrollment":20,"completionDate":"2024-10-25"},{"nctId":"NCT06705387","phase":"PHASE2","title":"Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE","status":"RECRUITING","sponsor":"University of Colorado, Denver","startDate":"2024-12-23","conditions":["Eosinophilic Esophagitis"],"enrollment":72,"completionDate":"2027-03"},{"nctId":"NCT06858423","phase":"PHASE4","title":"Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in Treating Allergic Rhinitis Patients","status":"COMPLETED","sponsor":"Benha University","startDate":"2023-08-15","conditions":["Nasal Allergy"],"enrollment":360,"completionDate":"2024-05-31"},{"nctId":"NCT02989935","phase":"PHASE4","title":"RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Calgary","startDate":"2016-04","conditions":["Copd"],"enrollment":30,"completionDate":"2026-07-01"},{"nctId":"NCT06234345","phase":"PHASE3","title":"Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)","status":"NOT_YET_RECRUITING","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-09","conditions":["Chronic Obstructive Pulmonary Disease"],"enrollment":1252,"completionDate":"2028-08"},{"nctId":"NCT01396278","phase":"PHASE2","title":"Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).","status":"TERMINATED","sponsor":"Boehringer Ingelheim","startDate":"2011-07-01","conditions":["Asthma"],"enrollment":9,"completionDate":"2011-12-14"},{"nctId":"NCT06806826","phase":"PHASE4","title":"The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study","status":"COMPLETED","sponsor":"Yuzuncu Yil University","startDate":"2019-01-01","conditions":["Allergic Rhinitis"],"enrollment":50,"completionDate":"2020-03-01"},{"nctId":"NCT02630121","phase":"PHASE4","title":"Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea","status":"RECRUITING","sponsor":"University of South Florida","startDate":"2023-04-01","conditions":["Sleep Apnea","Chronic Nasal Congestion"],"enrollment":52,"completionDate":"2026-04"},{"nctId":"NCT01624129","phase":"","title":"New Serological Markers for Eosinophilic Esophagitis","status":"UNKNOWN","sponsor":"Technical University of Munich","startDate":"2011-01","conditions":["Eosinophilic Esophagitis"],"enrollment":20,"completionDate":""},{"nctId":"NCT03040596","phase":"PHASE1","title":"The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children","status":"TERMINATED","sponsor":"Joseph Dohar, MD","startDate":"2017-03-01","conditions":["Vocal Fold Nodules"],"enrollment":2,"completionDate":"2019-01-23"},{"nctId":"NCT03072849","phase":"","title":"Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation","status":"COMPLETED","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2015-04","conditions":["Bronchiolitis Obliterans Syndrome"],"enrollment":23,"completionDate":"2020-09-01"},{"nctId":"NCT03002389","phase":"PHASE2","title":"Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Virginia","startDate":"2017-11-05","conditions":["Chronic Obstructive Pulmonary Disease"],"enrollment":95,"completionDate":"2028-01-31"},{"nctId":"NCT05444543","phase":"PHASE4","title":"Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2021-11-17","conditions":["Eosinophilic Esophagitis"],"enrollment":23,"completionDate":"2023-10-13"},{"nctId":"NCT06323304","phase":"NA","title":"Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis","status":"COMPLETED","sponsor":"University of Medicine and Pharmacy at Ho Chi Minh City","startDate":"2024-03-13","conditions":["Itching","Runny Nose","Sneezing","Nasal Congestion"],"enrollment":90,"completionDate":"2024-08-30"},{"nctId":"NCT06650917","phase":"PHASE1","title":"Acupoint Massage Combined With Ear Point Pressing Beans","status":"COMPLETED","sponsor":"Hai'an Hospital of TCM001","startDate":"2016-01-01","conditions":["Asthma"],"enrollment":120,"completionDate":"2022-12-01"},{"nctId":"NCT02402465","phase":"PHASE4","title":"Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2015-02","conditions":["Allergic Rhinitis"],"enrollment":22,"completionDate":"2020-02"},{"nctId":"NCT05192499","phase":"NA","title":"Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form","status":"RECRUITING","sponsor":"University Hospital, Brest","startDate":"2022-02-04","conditions":["Asthma in Children","Dysbiosis"],"enrollment":30,"completionDate":"2028-02-04"},{"nctId":"NCT03199976","phase":"PHASE4","title":"Efficacy of Intermittent Tiotropium in Early Childhood Wheezing","status":"TERMINATED","sponsor":"Helsinki University Central Hospital","startDate":"2016-04-20","conditions":["Wheezy Bronchitis","Asthmatic Bronchitis","Wheezing","Obstruction Airway"],"enrollment":80,"completionDate":"2020-11-18"},{"nctId":"NCT00545324","phase":"PHASE4","title":"First Step With Singulair® Therapy (0476-323)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-09","conditions":["Asthma"],"enrollment":399,"completionDate":"2003-12"},{"nctId":"NCT00817050","phase":"PHASE4","title":"Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-12-01","conditions":["Allergic Rhinitis"],"enrollment":100,"completionDate":"2005-01-01"},{"nctId":"NCT00489346","phase":"PHASE3","title":"A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-10","conditions":["Asthma, Bronchial"],"enrollment":994,"completionDate":"2002-06"},{"nctId":"NCT00763529","phase":"PHASE4","title":"Elocon vs Fluticasone in Localized Psoriasis (P03197)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-01-01","conditions":["Psoriasis"],"enrollment":245,"completionDate":"2005-01-01"},{"nctId":"NCT00783458","phase":"PHASE4","title":"Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-12-01","conditions":["Allergic Rhinitis"],"enrollment":100,"completionDate":"2005-01-01"},{"nctId":"NCT04527016","phase":"PHASE4","title":"Airway Microbiota Based Treatment of Asthma in Preschool Children","status":"COMPLETED","sponsor":"Children's Hospital of Fudan University","startDate":"2021-10-18","conditions":["Asthma in Children"],"enrollment":120,"completionDate":"2024-06-20"},{"nctId":"NCT00394355","phase":"PHASE4","title":"Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-09","conditions":["Asthma"],"enrollment":566,"completionDate":"2009-10"},{"nctId":"NCT00424008","phase":"PHASE3","title":"Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-04","conditions":["Asthma"],"enrollment":722,"completionDate":"2008-11"},{"nctId":"NCT00379288","phase":"PHASE3","title":"Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-06","conditions":["Asthma"],"enrollment":404,"completionDate":"2007-11"},{"nctId":"NCT00127166","phase":"PHASE3","title":"Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-12","conditions":["Exercise Induced Asthma"],"enrollment":154,"completionDate":"2008-11"},{"nctId":"NCT00284856","phase":"PHASE3","title":"Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-05","conditions":["Asthma"],"enrollment":1640,"completionDate":"2010-04"},{"nctId":"NCT01966692","phase":"PHASE1","title":"Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution","status":"COMPLETED","sponsor":"University of Florida","startDate":"2016-11","conditions":["Asthma"],"enrollment":24,"completionDate":"2018-01-20"},{"nctId":"NCT05080322","phase":"PHASE4","title":"Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis","status":"RECRUITING","sponsor":"Zheng Liu ENT","startDate":"2021-09-09","conditions":["Allergic Rhinitis"],"enrollment":150,"completionDate":"2025-01-01"},{"nctId":"NCT03858348","phase":"","title":"A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination","status":"COMPLETED","sponsor":"Elpen Pharmaceutical Co. Inc.","startDate":"2019-05-01","conditions":["COPD","COPD Exacerbation"],"enrollment":1000,"completionDate":"2019-12-31"},{"nctId":"NCT00235053","phase":"PHASE4","title":"Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID","status":"COMPLETED","sponsor":"Allergy & Asthma Medical Group & Research Center","startDate":"2005-08","conditions":["Asthma","Candidiasis, Oral","Voice Disorders"],"enrollment":13,"completionDate":"2005-11"},{"nctId":"NCT02889809","phase":"PHASE4","title":"Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-07-10","conditions":["Asthma"],"enrollment":477,"completionDate":"2021-06-04"},{"nctId":"NCT06180083","phase":"PHASE1","title":"Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray","status":"COMPLETED","sponsor":"Humanis Saglık Anonim Sirketi","startDate":"2023-03-24","conditions":["Seasonal Allergic Rhinitis","Perennial Allergic Rhinitis"],"enrollment":56,"completionDate":"2023-07-05"},{"nctId":"NCT05158972","phase":"","title":"Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2021-10-27","conditions":["Allergic Rhinitis"],"enrollment":924,"completionDate":"2023-10-24"},{"nctId":"NCT05127304","phase":"","title":"A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2021-02-26","conditions":["Pulmonary Disease, Chronic Obstructive"],"enrollment":11316,"completionDate":"2022-02-03"},{"nctId":"NCT01484210","phase":"PHASE3","title":"Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®","status":"COMPLETED","sponsor":"Elpen Pharmaceutical Co. Inc.","startDate":"2008-03","conditions":["Asthma"],"enrollment":28,"completionDate":"2008-10"},{"nctId":"NCT04601324","phase":"PHASE4","title":"Allergic Rhinitis Combination Pharmacotherapy Efficacy Study","status":"WITHDRAWN","sponsor":"St. Paul's Sinus Centre","startDate":"2020-12-15","conditions":["Allergic Rhinitis"],"enrollment":0,"completionDate":"2021-07-01"},{"nctId":"NCT00576069","phase":"","title":"Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma","status":"RECRUITING","sponsor":"Gelb, Arthur F., M.D.","startDate":"2007-10-25","conditions":["Asthma"],"enrollment":60,"completionDate":"2027-06"},{"nctId":"NCT01225913","phase":"PHASE4","title":"Mechanism(s) of Airflow Limitation During Exacerbation of Asthma","status":"RECRUITING","sponsor":"Gelb, Arthur F., M.D.","startDate":"2007-10","conditions":["Asthma"],"enrollment":50,"completionDate":"2027-06"},{"nctId":"NCT05169424","phase":"","title":"A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2021-12-17","conditions":["Pulmonary Disease, Chronic Obstructive"],"enrollment":9117,"completionDate":"2021-12-27"},{"nctId":"NCT06051786","phase":"PHASE2","title":"A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis","status":"COMPLETED","sponsor":"Synmosa Biopharma Corp.","startDate":"2020-08-20","conditions":["Allergic Rhinitis"],"enrollment":136,"completionDate":"2021-07-20"},{"nctId":"NCT05083312","phase":"PHASE3","title":"Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial","status":"COMPLETED","sponsor":"Ellodi Pharmaceuticals, LP","startDate":"2021-09-30","conditions":["Eosinophilic Esophagitis"],"enrollment":6,"completionDate":"2022-09-05"},{"nctId":"NCT06025214","phase":"PHASE1","title":"Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers","status":"UNKNOWN","sponsor":"Respirent Pharmaceuticals Co Ltd.","startDate":"2023-08-22","conditions":["Bioequivalence"],"enrollment":34,"completionDate":"2023-10-31"}],"_emaApprovals":[{"date":"2008-01-11","status":"Authorised","company":"GlaxoSmithKline (Ireland) Limited"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Nasal","formulation":"Powder, Spray","formulations":[{"form":"POWDER","route":"RESPIRATORY (INHALATION)","productName":"Arnuity Ellipta"},{"form":"POWDER","route":"RESPIRATORY (INHALATION)","productName":"Breo Ellipta"},{"form":"POWDER","route":"RESPIRATORY (INHALATION)","productName":"Trelegy Ellipta"},{"form":"POWDER","route":"RESPIRATORY (INHALATION)","productName":"Fluticasone Furoate and Vilanterol"},{"form":"SPRAY, METERED","route":"NASAL","productName":"FLONASE SENSIMISTALLERGY RELIEF"},{"form":"SPRAY, METERED","route":"NASAL","productName":"Veramyst"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000179800","MMSL":"109674","NDDF":"004952","UNII":"JS86977WNV","VUID":"4026165","CHEBI":"CHEBI:74899","VANDF":"4020529","INN_ID":"8521","RXNORM":"41126","UMLSCUI":"C1948374","chemblId":"CHEMBL1676","ChEMBL_ID":"CHEMBL1676","KEGG_DRUG":"D06315","DRUGBANK_ID":"DB08906","PDB_CHEM_ID":" GW6","PUBCHEM_CID":"9854489","SNOMEDCT_US":"108632003","IUPHAR_LIGAND_ID":"10892","SECONDARY_CAS_RN":"90566-53-3","MESH_DESCRIPTOR_UI":"D000068298","MESH_SUPPLEMENTAL_RECORD_UI":"C523187"},"formularyStatus":[],"originalProduct":{"form":"POWDER","route":"RESPIRATORY (INHALATION)","company":"GlaxoSmithKline LLC","brandName":"Arnuity Ellipta","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2007-","companyName":"GSK","relationship":"Original Developer"},{"period":"present","companyName":"Haleon Us Holdings","relationship":"Current Owner"},{"period":"2008","companyName":"GlaxoSmithKline (Ireland) Limited","relationship":"EMA Licensee"},{"period":"2009","companyName":"GlaxoSmithKline K.K.","relationship":"PMDA Licensee"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"10.6 hours","clearance":"13.4 mL/min/kg","bioavailability":"14%","volumeOfDistribution":"4.95 L/kg"},"publicationCount":638,"therapeuticAreas":["Respiratory"],"_revenueScrapedAt":"2026-04-08 13:59:06.852893+00","atcClassification":{"source":"DrugCentral","atcCode":"D07AC17","allCodes":["D07AC17","R01AD08","R01AD12","R01AD58","R03AK06","R03AK10","R03AK11","R03AL08","R03BA05","R03BA09"]},"biosimilarFilings":[],"originalDeveloper":"Glaxosmithkline","recentPublications":[{"date":"2026 Mar 16","pmid":"41817036","title":"Critical evaluation of fluticasone furoate/umeclidinium/vilanterol in asthma cough management: Insights and limitations from the COCOA study.","journal":"The Journal of asthma : official journal of the Association for the Care of Asthma"},{"date":"2026 Mar 2","pmid":"41801200","title":"Fluticasone- vs Budesonide-Based Dual Therapy for COPD.","journal":"JAMA network open"},{"date":"2026 Feb 14","pmid":"41753185","title":"Is Clinical Remission, an Ambitious Treatment Goal, Achievable in Patients with Moderate-to-Severe Asthma on Inhaled Therapies: How Ambitious Should We Be?","journal":"Journal of clinical medicine"},{"date":"2026 Feb 12","pmid":"41679900","title":"Economic evaluation of single-inhaler triple therapy for chronic obstructive pulmonary disease in Thailand.","journal":"BMJ open respiratory research"},{"date":"2026 Mar","pmid":"41673353","title":"A Pragmatic RCT of FF/UMEC/VI in Patients with Uncontrolled Asthma: PERFORM Protocol.","journal":"Pulmonary therapy"}],"combinationProducts":[{"brandName":"Breo Ellipta","ingredients":"fluticasone furoate + vilanterol"},{"brandName":"Trelegy Ellipta","ingredients":"fluticasone furoate + umeclidinium + vilanterol"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Haleon Us Holdings","companyId":"haleon-us-holdings","modality":"Small molecule","firstApprovalDate":"2007","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2007-04-27T00:00:00.000Z","mah":"GLAXOSMITHKLINE","brand_name_local":null,"application_number":""},{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2009-04-22T00:00:00.000Z","mah":"GlaxoSmithKline K.K.","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2011-09-01T00:00:00.000Z","mah":"HALEON US HOLDINGS","brand_name_local":null,"application_number":"NDA022051"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-08-20T00:00:00.000Z","mah":"GLAXOSMITHKLINE","brand_name_local":null,"application_number":"NDA205625"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2015-09-15T00:00:00.000Z","mah":"GLAXO GRP LTD","brand_name_local":null,"application_number":"NDA204275"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-12-02T00:00:00.000Z","mah":"GLAXOSMITHKLINE","brand_name_local":null,"application_number":"NDA209482"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":3,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T01:18:55.737314+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}