Last reviewed · How we verify
Fluticasone plus salmeterol fixed combination
Fluticasone (a corticosteroid) reduces airway inflammation while salmeterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing.
Fluticasone (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 plus salmeterol fixed combination |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol) |
| 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 bronchial smooth muscle, causing sustained bronchodilation. Together, this combination addresses both the inflammatory and obstructive components of asthma and COPD.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
- Muscle cramps
Key clinical trials
- Asthma Research in Children and Adolescents
- Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD (NA)
- Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1) (PHASE3)
- A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
- Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
- Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma. (PHASE3)
- Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma. (PHASE2)
- 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)
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 |