Fluticasone propionate and salmeterol

(Advair HFA®)

Advair HFA®

Drug updated on 9/5/2024

Dosage FormAerosol (inhalation; fluticasone propionate/salmeterol; 45 mcg/21 mcg, fluticasone propionate/salmeterol; 115 mcg/21 mcg, fluticasone propionate/salmeterol; 230 mcg/21 mcg)
Drug ClassCorticosteroids 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.

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Summary
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  • 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 TitleYearSource
Advair HFA (fluticasone propionate and salmeterol) Prescribing Information.2023GlaxoSmithKline, Durham, NC

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines