Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA
Autor: | Leslie Andersen, Loretta Jacques, David I. Bernstein, Louisa Yates, Richard Forth |
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Rok vydání: | 2017 |
Předmět: |
Adult
Male Pulmonary and Respiratory Medicine Adolescent Equivalence Trials as Topic Pharmacology Chlorobenzenes Drug Administration Schedule Fluticasone propionate Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Adrenal Cortex Hormones Forced Expiratory Volume Administration Inhalation Humans Immunology and Allergy Medicine In patient 030212 general & internal medicine Child Adrenergic beta-2 Receptor Agonists Benzyl Alcohols Asthma business.industry Middle Aged medicine.disease Fluticasone-Salmeterol Drug Combination Fluticasone furoate/vilanterol Bronchodilator Agents Androstadienes Drug Combinations 030228 respiratory system chemistry Ics laba Pediatrics Perinatology and Child Health Female Vilanterol Salmeterol Once daily business medicine.drug |
DOI: | 10.6084/m9.figshare.5457376 |
Popis: | 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 β2 agonist (ICS/LABA). 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 (FEV1). Secondary endpoints included rescue-/symptom-free 24-hour periods. Safety was also assessed. 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 FEV1 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 FEV1 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. Conclusions: FF/VI was non-inferior to FP/SAL for evening trough FEV1 at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control. |
Databáze: | OpenAIRE |
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