Fluticasone propionate/salmeterol

(Advair HFA®)

Fluticasone propionate/salmeterol

Drug updated on 12/11/2024

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 beta-2 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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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Health-Related Quality of Life and Asthma Control: Fluticasone propionate/salmeterol (FP/Sal) improved health-related quality of life (HRQoL) with an Asthma Quality of Life Questionnaire (AQLQ) change from baseline (CFB) of 0.65 vs. placebo, 0.58 vs. long-acting beta agonist (LABA), 0.21 vs. inhaled corticosteroids (ICS) alone, 0.06 vs. other ICS/LABA, and 0.00 vs. ICS/formoterol maintenance and reliever therapy (MART). These HRQoL improvements were strongly correlated with Asthma Control Questionnaire (ACQ) scores (R = 0.94).
  • Asthma Exacerbation and Control in Children: Salmeterol/fluticasone (SFC) in children and adolescents (4-18 years) was associated with a lower risk of asthma exacerbation, improved peak expiratory flow (PEF)%pred, asthma control levels, and better scores on the childhood asthma control test compared to montelukast and the montelukast/fluticasone combination (MFC).
  • Comparison with Formoterol/Budesonide (FB): The FB pressurized metered-dose inhaler (pMDI) showed benefits in lung function, asthma control, and reduced symptoms and exacerbations for patients aged 6 years and older, indicating effective management in pediatric asthma.
  • General Safety Profile: FP/Sal showed no significant increase in adverse events compared to other treatments, with similar safety profiles observed between formoterol/budesonide and salmeterol/fluticasone combinations, including no significant differences in mortality or non-fatal serious adverse events.
  • Pediatric Safety: In children and adolescents, SFC and MFC showed comparable safety profiles, with no significant differences in adverse events. Additionally, fluticasone propionate/formoterol (FP/FORM) in pediatric patients had a lower incidence of nasopharyngitis compared to FP/Sal.
  • Population Types and Subgroup Considerations: In moderate-to-severe asthma patients, FP/Sal was effective in improving HRQoL and asthma control. For children and adolescents aged 4-18 years, salmeterol/fluticasone (SFC) showed greater benefits in asthma control and reduced exacerbations compared to MFC. Among pediatric patients aged 6 and older, the formoterol/budesonide (FB) pressurized metered-dose inhaler (pMDI) demonstrated improved long-term asthma management outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Advair HFA (fluticasone propionate/salmeterol) Prescribing Information.2024GlaxoSmithKline, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines