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fluticasone/salmeterol DISKUS 250/50
Fluticasone propionate (inhaled corticosteroid) reduces airway inflammation while salmeterol (long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing.
Fluticasone propionate (inhaled corticosteroid) reduces airway inflammation while salmeterol (long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance treatment, Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | fluticasone/salmeterol DISKUS 250/50 |
|---|---|
| Sponsor | Allergy & Asthma Medical Group & Research Center |
| 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 is a potent glucocorticoid that suppresses inflammatory cytokines and immune cell recruitment in the airways. Salmeterol is a long-acting beta-2 adrenergic agonist 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
- Throat irritation
Key clinical trials
- Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1) (PHASE3)
- Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID (PHASE4)
- Mechanism(s) of Airflow Limitation During Exacerbation of Asthma (PHASE4)
- Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
- Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs (PHASE1)
- Non-invasive Measures of Distal Lung Disease in Asthmatics (PHASE4)
- 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)
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 |
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