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Fluticasone propionate/salmeterol Inhalation Powder
Fluticasone propionate/salmeterol Inhalation Powder is a Inhaled corticosteroid/long-acting beta-2 agonist combination Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
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 propionate/salmeterol Inhalation Powder |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
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 therapy.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness/anxiety
- Oral candidiasis
- Hoarseness
- Palpitations
Key clinical trials
- Asthma Research in Children and Adolescents
- Acupoint Massage Combined With Ear Point Pressing Beans (PHASE1)
- Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1) (PHASE3)
- Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911) (PHASE3)
- 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)
- A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma (PHASE4)
- Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers (PHASE1)
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 propionate/salmeterol Inhalation Powder CI brief — competitive landscape report
- Fluticasone propionate/salmeterol Inhalation Powder updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Fluticasone propionate/salmeterol Inhalation Powder
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Related
- Drug class: All Inhaled corticosteroid/long-acting beta-2 agonist combination drugs
- Target: All drugs targeting Glucocorticoid receptor; beta-2 adrenergic receptor
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Asthma maintenance therapy
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Compare: Fluticasone propionate/salmeterol Inhalation Powder vs similar drugs
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