Drug updated on 9/5/2024
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 | 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.
Latest News
Summary
- Advair HFA (fluticasone propionate and salmeterol) is indicated for the treatment of asthma in adult and adolescent patients aged 12 years and older.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- HRQoL in Asthma (Moderate-to-Severe Asthma): FP/Sal demonstrated significant improvements in HRQoL, with a mean difference in AQLQ CFB of 0.65 compared to placebo, 0.58 versus LABA, and 0.21 against ICS alone. No significant differences were observed when compared to other ICS/LABA combinations (0.06) or ICS/formoterol MART (0.00).
- Pediatric Asthma (FP/SAL vs. FP/FORM): FP/SAL resulted in better pre-dose FEV1, asthma symptom scores, and sleep disturbance scores, while FP/FORM showed superiority in PEFR. No significant differences were noted in 2-hour post-dose FEV1 or other lung function parameters.
- COPD (LABA/LAMA vs. ICS/LABA): LABA/LAMA combinations, including umeclidinium/vilanterol, glycopyrronium/indacaterol, and glycopyrrolate/formoterol fumarate, were more effective than ICS/LABA combinations in improving trough FEV1 and reducing the risk of COPD exacerbations.
- Regular use of formoterol/salmeterol combined with ICS did not show significant differences in mortality or non-fatal serious adverse events when comparing formoterol/budesonide and salmeterol/fluticasone. Few asthma-related serious adverse events were reported, leading to low confidence in the safety conclusions.
- In pediatric asthma, no significant differences in overall adverse events were observed between FP/SAL and FP/FORM, though FP/FORM was associated with a lower incidence of nasopharyngitis.
- The reviewed studies indicate that patients with moderate-to-severe asthma, pediatric asthma, chronic asthma in adults and adolescents, and moderate-to-severe COPD were the primary populations studied, with clinically relevant findings highlighting HRQoL improvements with FP/Sal in moderate-to-severe asthma, differing efficacy in lung function between FP/SAL and FP/FORM in pediatric asthma, comparable safety profiles in chronic asthma treatments, and superior efficacy of LABA/LAMA combinations over ICS/LABA in improving lung function and reducing exacerbations in COPD.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Advair HFA (fluticasone propionate and salmeterol) Prescribing Information. | 2023 | GlaxoSmithKline, Durham, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Impact of inhaled fluticasone propionate/salmeterol on health-related quality of life in asthma: a network meta-analysis. | 2022 | Respiratory Medicine |
Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events. | 2021 | The Cochrane Database of Systematic Reviews |
Comparing the efficacy and safety of formoterol/budesonide pMDI versus its mono-components and other LABA/ICS in patients with asthma. | 2020 | Respiratory Medicine |
The efficacy and safety of fluticasone propionate/formoterol compared with fluticasone propionate/salmeterol in treating pediatric asthma: a systematic review and meta-analysis. | 2020 | Journal of International Medical Research |
Impact of ICS/LABA and LABA/LAMA FDCs on functional and clinical outcomes in COPD: a network meta-analysis. | 2019 | Pulmonary Pharmacology and Therapeutics |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
How do we manage asthma? Assessment of knowledge, attitude, and practice patterns among pulmonologists and allergists. | 2023 | The Journal of Asthma |
2022 GINA report, global strategy for asthma management and prevention. | 2022 | Global Initiative for Asthma |
Asthma guideline updates. | 2022 | ACSAP: Pulmonary Care |
Are the Global Initiative for Asthma (GINA) Guidelines Being Correctly Used to Diagnose Severe Asthma in the UAE? | 2020 | Cureus |