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Fluticasone/Salmeterol HFA
Fluticasone propionate (a corticosteroid) reduces airway inflammation while salmeterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing.
Fluticasone propionate (a corticosteroid) reduces airway inflammation while salmeterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Fluticasone/Salmeterol HFA |
|---|---|
| Sponsor | GlaxoSmithKline |
| 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 |
| Phase | FDA-approved |
Mechanism of action
Fluticasone propionate binds to glucocorticoid receptors in the lungs, suppressing inflammatory cytokine production and reducing airway edema and mucus secretion. Salmeterol activates beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and sustained airway opening. Together, they provide both anti-inflammatory and bronchodilator effects for maintenance asthma and COPD control.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness
- Oral candidiasis
- Palpitations
- Muscle cramps
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)
- Advair HFA in Healthy and HAPE Predisposed Subjects (PHASE1, PHASE2)
- Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes (NA)
- Non-invasive Measures of Distal Lung Disease in Asthmatics (PHASE4)
- Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma (PHASE3)
- Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma (PHASE3)
- 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)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fluticasone/Salmeterol HFA CI brief — competitive landscape report
- Fluticasone/Salmeterol HFA updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI