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Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA.
- Source :
-
The Journal of asthma : official journal of the Association for the Care of Asthma [J Asthma] 2018 Sep; Vol. 55 (9), pp. 984-993. Date of Electronic Publication: 2018 Apr 13. - Publication Year :
- 2018
-
Abstract
- Objective: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β <subscript>2</subscript> agonist (ICS/LABA).<br />Methods: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 µg for 24 weeks. Primary endpoint was change from baseline in evening trough forced expiratory volume in 1 second (FEV <subscript>1</subscript> ). Secondary endpoints included rescue-/symptom-free 24-hour periods. Safety was also assessed.<br />Results: The intent-to-treat (ITT) population included 1504 randomized and treated patients (504 FF/VI; 501 FP/SAL; 499 FP); mean age 43.5 years, 64% female. FF/VI demonstrated non-inferiority (using a margin of -100 mL) to FP/SAL for evening trough FEV <subscript>1</subscript> at Week 24 (ITT: 19 mL [95% confidence interval (CI) -11 to 49]; per protocol population [N = 1336]: 6 mL [95% CI -27 to 40]). Improvement in evening trough FEV <subscript>1</subscript> at Week 24 for both FF/VI (123 mL; p < 0.001) and FP/SAL (104 mL; p < 0.001) was greater than FP. FF/VI increased rescue-/symptom-free 24-hour periods by 1.2%/1.2% compared with FP/SAL. All treatments were well tolerated. On-treatment adverse event (AE) rates were 43% to 45% across arms; there were no drug-related serious AEs.<br />Conclusions: FF/VI was non-inferior to FP/SAL for evening trough FEV <subscript>1</subscript> at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control.
- Subjects :
- Administration, Inhalation
Adolescent
Adrenal Cortex Hormones therapeutic use
Adrenergic beta-2 Receptor Agonists therapeutic use
Adult
Androstadienes administration & dosage
Benzyl Alcohols administration & dosage
Bronchodilator Agents administration & dosage
Child
Chlorobenzenes administration & dosage
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Equivalence Trials as Topic
Female
Fluticasone-Salmeterol Drug Combination administration & dosage
Forced Expiratory Volume
Humans
Male
Middle Aged
Young Adult
Androstadienes therapeutic use
Asthma drug therapy
Benzyl Alcohols therapeutic use
Bronchodilator Agents therapeutic use
Chlorobenzenes therapeutic use
Fluticasone-Salmeterol Drug Combination therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1532-4303
- Volume :
- 55
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- The Journal of asthma : official journal of the Association for the Care of Asthma
- Publication Type :
- Academic Journal
- Accession number :
- 28961020
- Full Text :
- https://doi.org/10.1080/02770903.2017.1386214