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Fluticasone/Salmeterol high dose
Fluticasone/Salmeterol is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and dilates airways to improve breathing.
Fluticasone/Salmeterol is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and dilates airways to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Fluticasone/Salmeterol high dose |
|---|---|
| Also known as | COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day) |
| Sponsor | Far Eastern Memorial Hospital |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Fluticasone propionate is a potent inhaled corticosteroid that suppresses inflammatory responses in the airways by binding to glucocorticoid receptors, reducing mucus production and airway edema. Salmeterol is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle, causing bronchodilation and lasting up to 12 hours. The combination provides both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness/anxiety
- Palpitations
- Muscle cramps
- Oral candidiasis
- Dysphonia
Key clinical trials
- 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 (PHASE4)
- Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139) (PHASE3)
- Study to Determine the Pharmacokinetics and Tolerability of Fluticasone Propionate MDPI and Fluticasone Propionate/Salmeterol MDPI Compared to High Strength FLOVENT® DISKUS® and ADVAIR® DISKUS® in Patients With Persistent Asthma 12 Years of Age and Older (PHASE1)
- Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma (PHASE3)
- Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma. (PHASE3)
- Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years (PHASE3)
- Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma (PHASE3)
- A Single Centre Study in Healthy Volunteers to Optimise the Rotacap Formulation and ROTAHALER Device for Delivery of Fluticasone Propionate/Salmeterol (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |