title: A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD.
abstract: Fluticasone furoate/vilanterol trifenatate (FF/VI) is a once-daily inhaled corticosteroid/long-acting β₂-agonist combination in development for chronic obstructive pulmonary disease (COPD) treatment. We compared the efficacy and safety of FF/VI versus fluticasone propionate/salmeterol (FP/SAL) twice daily over 12 weeks. Moderate to very severe COPD patients received FF/VI 100/25 μg once daily in the morning (n=266) or FP/SAL 500/50 μg twice daily (n=262). The primary end-point was a change from baseline in 0-24 h weighted mean forced expiratory volume in 1 s (wmFEV₁) at 12 weeks. Additional end-points included time to 100 mL improvement from baseline on day 1 and a change from baseline in St George's Respiratory Questionnaire (SGRQ). Safety was also assessed. wmFEV₁ (mean 130 mL) was greater and time to 100 mL improvement shorter (median 16 min) with FF/VI than FP/SAL (weighted mean 108 mL, median 28 min). Health status (SGRQ total score) improved in both groups (FF/VI -4.3 units, FP/SAL -3.0 units). Differences between treatments were not statistically significant. Six patients in the FF/VI (2%) and three in the FP/SAL (1%) arm experienced serious adverse events, none of which were considered to be drug related. Improvements in lung function and health status were not significantly different between FF/VI 100/25 μg once daily and FP/SAL 500/50 μg twice daily; there was no apparent difference between the safety profiles of either therapy.
authors.affiliation: Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona.
authors.forename: Alvar
authors.initials: A
authors.lastname: Agustí
authors.forename: Luis
authors.initials: L
authors.lastname: de Teresa
authors.forename: Wilfried
authors.initials: W
authors.lastname: De Backer
authors.forename: Michael T
authors.initials: MT
authors.lastname: Zvarich
authors.forename: Nicholas
authors.initials: N
authors.lastname: Locantore
authors.forename: Neil
authors.initials: N
authors.lastname: Barnes
authors.forename: Jean
authors.initials: J
authors.lastname: Bourbeau
authors.forename: Courtney
authors.initials: C
authors.lastname: Crim
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001592:Benzyl Alcohols / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage; D002722:Chlorobenzenes / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D012907:Smoking / Q000009:adverse effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; C550468:vilanterol; C523187:fluticasone furoate; D000420:Albuterol