{"id":"inhaled-tobramycin","safety":{"commonSideEffects":[{"rate":null,"effect":"Cough"},{"rate":null,"effect":"Wheezing"},{"rate":null,"effect":"Dyspnea"},{"rate":null,"effect":"Tinnitus"},{"rate":null,"effect":"Voice alteration"},{"rate":null,"effect":"Bronchospasm"}]},"_chembl":{"chemblId":"CHEMBL3989564","moleculeType":"Small molecule","molecularWeight":"1425.44"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Inhaled tobramycin delivers the antibiotic directly to the respiratory tract at high local concentrations. It irreversibly binds to the 30S ribosomal subunit of gram-negative bacteria, preventing accurate translation of mRNA and causing bacterial cell death. This direct lung delivery minimizes systemic exposure while achieving therapeutic concentrations in airway secretions.","oneSentence":"Tobramycin is an aminoglycoside antibiotic that binds to bacterial ribosomes and inhibits protein synthesis, killing susceptible bacteria in the lungs.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:48:53.408Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cystic fibrosis with Pseudomonas aeruginosa lung infection"},{"name":"Chronic Pseudomonas aeruginosa airway colonization in cystic fibrosis patients"}]},"trialDetails":[{"nctId":"NCT07463339","phase":"PHASE2","title":"Microbiome-guided Prophylaxis to Reduce Ventilator-Associated Pneumonia in Intensive Care Units: A Pilot Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"University of Calgary","startDate":"2026-05-01","conditions":"Critical Illness, Mechanical Ventilation","enrollment":70},{"nctId":"NCT06016088","phase":"PHASE1, PHASE2","title":"A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection","status":"RECRUITING","sponsor":"Respirion Pharmaceuticals Pty Ltd","startDate":"2024-04-01","conditions":"Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa","enrollment":72},{"nctId":"NCT06760273","phase":"","title":"Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)","status":"RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2024-10-16","conditions":"Bronchiectasis Adult","enrollment":364},{"nctId":"NCT04560179","phase":"PHASE1","title":"Inhaled Tobramycin in BPD","status":"COMPLETED","sponsor":"Erik Allen Jensen","startDate":"2022-03-22","conditions":"Bronchopulmonary Dysplasia","enrollment":27},{"nctId":"NCT06093191","phase":"PHASE4","title":"Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis","status":"RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2023-09-25","conditions":"Bronchiectasis Adult, Pseudomonas Aeruginosa Infection","enrollment":364},{"nctId":"NCT01270347","phase":"PHASE3","title":"Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-01","conditions":"Cystic Fibrosis","enrollment":282},{"nctId":"NCT02038803","phase":"","title":"Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution","status":"TERMINATED","sponsor":"Rush University Medical Center","startDate":"2013-10-10","conditions":"Cystic Fibrosis","enrollment":5},{"nctId":"NCT06106789","phase":"","title":"A Study of the Clinical Benefit of Tobramycin Inhalation Solution","status":"ACTIVE_NOT_RECRUITING","sponsor":"Qianfoshan Hospital","startDate":"2023-04-01","conditions":"Bronchiectasis, Cystic Fibrosis, Lung Infection","enrollment":1600},{"nctId":"NCT02888730","phase":"PHASE3","title":"Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients","status":"TERMINATED","sponsor":"Virginie ESCABASSE","startDate":"2017-02-16","conditions":"Cystic Fibrosis, Rhinosinusitis, Lung Diseases","enrollment":86},{"nctId":"NCT02449031","phase":"","title":"Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2015-05-05","conditions":"Pseudomonas Aeruginosa in Cystic Fibrosis","enrollment":409},{"nctId":"NCT03502070","phase":"PHASE4","title":"Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2018-06-26","conditions":"Cystic Fibrosis","enrollment":47},{"nctId":"NCT03485456","phase":"PHASE1, PHASE2","title":"DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis","status":"UNKNOWN","sponsor":"University Medical Center Groningen","startDate":"2019-05-29","conditions":"Cystic Fibrosis","enrollment":10},{"nctId":"NCT03066453","phase":"PHASE3","title":"Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis","status":"TERMINATED","sponsor":"University Hospital, Lille","startDate":"2017-06-13","conditions":"Cystic Fibrosis","enrollment":23},{"nctId":"NCT02440828","phase":"PHASE4","title":"Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia","status":"COMPLETED","sponsor":"Erasmus Medical Center","startDate":"2015-03","conditions":"Ventilator Associated Pneumonia (VAP)","enrollment":80},{"nctId":"NCT02677701","phase":"PHASE4","title":"Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)","status":"COMPLETED","sponsor":"Seattle Children's Hospital","startDate":"2016-10-21","conditions":"Cystic Fibrosis","enrollment":119},{"nctId":"NCT01069705","phase":"PHASE3","title":"Second Open Label Extension to Bridging Study CTBM100C2303","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-02-12","conditions":"Pulmonary Infections, Pseudomonas Aeruginosa","enrollment":49},{"nctId":"NCT00982930","phase":"PHASE3","title":"Open Label Extension to Bridging Study CTBM100C2303","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-08-12","conditions":"Pseudomonas Aeruginosa, Cystic Fibrosis","enrollment":55},{"nctId":"NCT02212587","phase":"PHASE1","title":"Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex","status":"COMPLETED","sponsor":"Unity Health Toronto","startDate":"2014-09","conditions":"Cystic Fibrosis, Burkholderia Cepacia Infection","enrollment":10},{"nctId":"NCT02712983","phase":"PHASE2","title":"Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-02-08","conditions":"Non-cystic Fibrosis Bronchiectasis","enrollment":107},{"nctId":"NCT01116089","phase":"PHASE1","title":"Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2010-07","conditions":"Cystic Fibrosis","enrollment":25},{"nctId":"NCT01315678","phase":"PHASE3","title":"Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2012-02-29","conditions":"Pseudomonas Aeruginosa Infection","enrollment":302},{"nctId":"NCT02657473","phase":"PHASE2, PHASE3","title":"Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis","status":"COMPLETED","sponsor":"Medical Center Alkmaar","startDate":"2016-08-13","conditions":"Non-CF Bronchiectasis","enrollment":58},{"nctId":"NCT02054156","phase":"PHASE3","title":"OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis","status":"COMPLETED","sponsor":"Bonnie Ramsey","startDate":"2014-06","conditions":"Cystic Fibrosis","enrollment":221},{"nctId":"NCT03715322","phase":"PHASE3","title":"Tobramycin in Bronchiectasis Colonized With Pseudmonas Aeruginosa","status":"UNKNOWN","sponsor":"Guangzhou Institute of Respiratory Disease","startDate":"2018-10-26","conditions":"Bronchiectasis Adult, Pseudomonas Infections","enrollment":350},{"nctId":"NCT02248922","phase":"PHASE4","title":"Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-01-27","conditions":"Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis","enrollment":17},{"nctId":"NCT02113397","phase":"","title":"Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung","status":"TERMINATED","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"2014-04","conditions":"Cystic Fibrosis","enrollment":1},{"nctId":"NCT03341741","phase":"PHASE3","title":"Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients","status":"COMPLETED","sponsor":"University Hospital Tuebingen","startDate":"2014-03-11","conditions":"Cystic Fibrosis With Pulmonary Manifestations","enrollment":26},{"nctId":"NCT02207426","phase":"PHASE1","title":"Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™","status":"COMPLETED","sponsor":"Pharmaero ApS","startDate":"2014-07","conditions":"Healthy","enrollment":12},{"nctId":"NCT02015663","phase":"PHASE4","title":"Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-01","conditions":"Cystic Fibrosis","enrollment":32},{"nctId":"NCT00634192","phase":"PHASE3","title":"Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin","status":"COMPLETED","sponsor":"Novartis","startDate":"2008-02","conditions":"Pseudomonas Infections","enrollment":50},{"nctId":"NCT01844778","phase":"PHASE4","title":"Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2013-08","conditions":"Cystic Fibrosis","enrollment":60},{"nctId":"NCT01082367","phase":"PHASE3","title":"Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-04","conditions":"Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients","enrollment":50},{"nctId":"NCT02178540","phase":"PHASE4","title":"Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-08","conditions":"Cystic Fibrosis","enrollment":45},{"nctId":"NCT01641822","phase":"PHASE3","title":"Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2012-12","conditions":"Cystic Fibrosis","enrollment":107},{"nctId":"NCT01775137","phase":"PHASE4","title":"Ext. Long-term Safety Study in CF Patients: Single Arm TIP","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2013-02","conditions":"Long-term Safety of TIP","enrollment":45},{"nctId":"NCT01319253","phase":"","title":"A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies","status":"COMPLETED","sponsor":"Indiana University","startDate":"2011-03","conditions":"Cystic Fibrosis, Pseudomonas Aeruginosa","enrollment":27},{"nctId":"NCT00004829","phase":"PHASE3","title":"Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis","status":"COMPLETED","sponsor":"FDA Office of Orphan Products Development","startDate":"1995-06","conditions":"Cystic Fibrosis, Bacterial Infection","enrollment":200},{"nctId":"NCT01519661","phase":"PHASE4","title":"Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-01","conditions":"Pulmonary Infections, Pseudomonas Aeruginosa in Cystic Fibrosis","enrollment":157},{"nctId":"NCT02035488","phase":"PHASE1, PHASE2","title":"Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2013-10","conditions":"Bronchiectasis","enrollment":8},{"nctId":"NCT00774072","phase":"PHASE2","title":"Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization","status":"COMPLETED","sponsor":"University of Jena","startDate":"2008-10","conditions":"Cystic Fibrosis, Pseudomonas Aeruginosa","enrollment":9},{"nctId":"NCT01953367","phase":"PHASE1","title":"Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects","status":"COMPLETED","sponsor":"Pari Pharma GmbH","startDate":"2013-09","conditions":"Cystic Fibrosis","enrollment":72},{"nctId":"NCT00097773","phase":"PHASE2","title":"Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis","status":"COMPLETED","sponsor":"Seattle Children's Hospital","startDate":"2004-09","conditions":"Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive","enrollment":304},{"nctId":"NCT00794586","phase":"PHASE2","title":"Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2008-11","conditions":"Cystic Fibrosis","enrollment":120},{"nctId":"NCT01749644","phase":"","title":"Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life","status":"UNKNOWN","sponsor":"Sheba Medical Center","startDate":"2013-01","conditions":"Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler","enrollment":40},{"nctId":"NCT00918957","phase":"PHASE3","title":"A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-06","conditions":"Cystic Fibrosis","enrollment":62},{"nctId":"NCT00388505","phase":"PHASE3","title":"Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-02","conditions":"Cystic Fibrosis","enrollment":517},{"nctId":"NCT01608555","phase":"PHASE4","title":"Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Milan","startDate":"2012-01","conditions":"Cystic Fibrosis","enrollment":10},{"nctId":"NCT01460836","phase":"","title":"Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-04","conditions":"Cystic Fibrosis","enrollment":""},{"nctId":"NCT00125346","phase":"PHASE3","title":"Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects","status":"TERMINATED","sponsor":"Novartis","startDate":"2005-09","conditions":"Cystic Fibrosis","enrollment":98},{"nctId":"NCT00391976","phase":"PHASE3","title":"Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis","status":"COMPLETED","sponsor":"Novartis","startDate":"2003-11","conditions":"Cystic Fibrosis","enrollment":123},{"nctId":"NCT01400750","phase":"PHASE4","title":"Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis","status":"COMPLETED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2001-08","conditions":"Cystic Fibrosis","enrollment":61},{"nctId":"NCT00757237","phase":"PHASE3","title":"Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2008-08","conditions":"Cystic Fibrosis","enrollment":274},{"nctId":"NCT00547053","phase":"PHASE1","title":"Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis","status":"COMPLETED","sponsor":"Boston Children's Hospital","startDate":"2006-12","conditions":"Cystic Fibrosis","enrollment":25},{"nctId":"NCT00823238","phase":"PHASE1","title":"Comparison of Antibiotics for Pseudomonas in Early CF","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2004-07","conditions":"Cystic Fibrosis","enrollment":21},{"nctId":"NCT00006280","phase":"PHASE2","title":"A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2000-02","conditions":"Cystic Fibrosis","enrollment":98},{"nctId":"NCT00447837","phase":"PHASE2","title":"Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis","status":"COMPLETED","sponsor":"Naryx Pharma","startDate":"2006-10","conditions":"Chronic Sinusitis","enrollment":180},{"nctId":"NCT00399945","phase":"PHASE1","title":"Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-05","conditions":"Cystic Fibrosis","enrollment":12},{"nctId":"NCT00420836","phase":"PHASE1","title":"Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-04","conditions":"Cystic Fibrosis","enrollment":20}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"BLOOD PRESSURE SYSTOLIC ABNORMAL"},{"count":1,"reaction":"CHILLS"},{"count":1,"reaction":"DIARRHOEA"},{"count":1,"reaction":"DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS"},{"count":1,"reaction":"ERYTHEMA"},{"count":1,"reaction":"EYE SWELLING"},{"count":1,"reaction":"HYPOAESTHESIA ORAL"},{"count":1,"reaction":"HYPOTENSION"},{"count":1,"reaction":"NEPHROPATHY"},{"count":1,"reaction":"PRURITUS"}],"_approvalHistory":[],"publicationCount":233,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"inhaled tobramycin","genericName":"inhaled tobramycin","companyName":"Seattle Children's Hospital","companyId":"seattle-children-s-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tobramycin is an aminoglycoside antibiotic that binds to bacterial ribosomes and inhibits protein synthesis, killing susceptible bacteria in the lungs. Used for Cystic fibrosis with Pseudomonas aeruginosa lung infection, Chronic Pseudomonas aeruginosa airway colonization in cystic fibrosis patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}