Drug updated on 4/17/2024
| Dosage Form | Aerosol (inhalation; fluticasone propionate/salmeterol; 45 mcg/21 mcg, fluticasone propionate/salmeterol; 115 mcg/21 mcg, fluticasone propionate/salmeterol; 230 mcg/21 mcg) |
| Drug Class | Inhaled corticosteroids and long-acting beta2-adrenergic agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of asthma in adult and adolescent patients aged 12 years and older.
Summary
- Fluticasone propionate and salmeterol (Advair HFA) is indicated for the treatment of asthma in adult and adolescent patients aged 12 years and older.
- Three randomized controlled trials were reviewed to gather information about this drug's effectiveness, safety, comparison with other drugs, as well as its impact on specific patient populations.
- A phase IV clinical study demonstrated that fluticasone propionate/salmeterol administered via a metered-dose inhaler hydrofluoroalkane was non-inferior to the same combination delivered through a dry-powder inhaler; it also resulted in fewer incidences of hoarseness among adults with asthma.
- The PALLADIUM study showed that once-daily fixed-dose combinations (FDCs) of mometasone furoate plus indacaterol acetate significantly improved lung function over ICS monotherapy at week 26; high-dose MF-IND was found to be non-inferior to twice-daily combination of ICS and LABA for improvement in trough FEV1.
- In another trial known as IRIDIUM study, single-inhaler combination therapy involving mometasone furoate, indacaterol acetate, and glycopyrronium bromide proved superior in improving lung function compared to both corresponding doses of MF-IND at week 26 and high dose FLU-SAL at week 26 among patients with inadequately controlled asthma despite being on medium or high dose ICS-LABA therapy.
- Across all three studies reviewed, no major differences were observed regarding adverse events across different treatment groups indicating comparable safety profiles between these therapies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Advair HFA (fluticasone propionate and salmeterol) Prescribing Information. | 2023 | GlaxoSmithKline, Durham, NC |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - a randomized, multi-center, non-inferiority, phase iv clinical study. | 231Subjects F: 60% M: 40% | 2021 | Respiratory Medicine |
| Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. | 2,216Subjects F: 58% M: 42% | 2020 | The Lancet Respiratory Medicine |
| Once-daily, single-inhaler mometasone–indacaterol–glycopyrronium versus mometasone–indacaterol or twice-daily fluticasone–salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. | 3,092Subjects F: 62% M: 38% | 2020 | The Lancet Respiratory Medicine |
Sex Distribution:
F:60%
M:40%
231Subjects
Year:
2021
Source:Respiratory Medicine
Sex Distribution:
F:58%
M:42%
2216Subjects
Year:
2020
Source:The Lancet Respiratory Medicine
Sex Distribution:
F:62%
M:38%
3092Subjects
Year:
2020
Source:The Lancet Respiratory Medicine
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 2022 GINA report, global strategy for asthma management and prevention. | 2022 | GINA |
| Asthma guideline updates. | 2022 | ACSAP: Pulmonary Care |