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Fluticasone/salmeterol (FSC)
Fluticasone/salmeterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle.
Fluticasone/salmeterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle. Used for Asthma maintenance treatment, Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | Fluticasone/salmeterol (FSC) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Fluticasone propionate is an 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 (LABA) that binds to beta-2 receptors on airway smooth muscle, causing bronchodilation and lasting 12+ hours. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance treatment
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Nervousness/anxiety
- Palpitations
- Oral candidiasis
- Hoarseness
Key clinical trials
- A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma (PHASE3)
- A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise (PHASE4)
- Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old (PHASE4)
- SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. (PHASE4)
- ROTAHALER Device Optimization Study (PHASE1)
- Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study (PHASE4)
- A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (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 (FSC) CI brief — competitive landscape report
- Fluticasone/salmeterol (FSC) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI