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Fluticasone/Salmeterol Diskus
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 therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Fluticasone/Salmeterol Diskus |
|---|---|
| Also known as | Fluticasone, Salmeterol |
| Sponsor | Johns Hopkins University |
| 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 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 therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness
- Oral candidiasis
- Palpitations
- Muscle cramps
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)
- Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus® (PHASE3)
- Mechanism(s) of Airflow Limitation During Exacerbation of Asthma (PHASE4)
- Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
- Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
- Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
- Bioequivalence With Clinical Endpoint Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |