Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT

• Published in: Therapeutic advances in respiratory disease Vol. 14; p. 1753466620963021
• Main Authors: Marín, José M., Mateos, Luis, Roldán, Juan, Echave-Sustaeta, José M., Pascual-Guardia, Sergi, Pardo, Maria V., Velasco, Beatriz, Jones, C. Elaine, Kilbride, Sally, Lipson, David A.
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 2020; SAGE PUBLICATIONS, INC; SAGE Publishing
• Subjects: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Androstadienes - administration & dosage; Androstadienes - adverse effects; Benzyl Alcohols - administration & dosage; Benzyl Alcohols - adverse effects; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Chlorobenzenes - administration & dosage; Chlorobenzenes - adverse effects; Chronic obstructive pulmonary disease; Disease Progression; Double-Blind Method; Drug Combinations; Female; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Humans; Inhalers; Lung - drug effects; Lung - physiopathology; Male; Middle Aged; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Nebulizers and Vaporizers; Original Research; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Quinuclidines - administration & dosage; Quinuclidines - adverse effects; Recovery of Function; Spain; Time Factors; Treatment Outcome; Spain; Chronic obstructive pulmonary disease (COPD); randomized clinical trial; glucocorticoid; LAMA; triple therapy; LABA
• ISSN: 1753-4666; 1753-4658; 1753-4666
• DOI: 10.1177/1753466620963021

Objectives: The IMPACT trial has compared the benefit in the reduction of moderate/severe exacerbations of single inhaler triple therapy (SITT) with fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus dual therapy with FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA) in the treatment of patients with chronic obstructive disease (COPD). This study performs a subgroup analysis of the cohort from Spain in the IMPACT study. Materials and Methods: In IMPACT, a 52-week randomized, double-blind, parallel-group, multicenter study (N = 10,355), patients ⩾40 years of age with COPD and ⩾1 moderate/severe exacerbations in the previous year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Here, we present a subgroup analysis of the 499 patients from Spain, included in the intent-to-treat (ITT) population in the study. Endpoint assessed included exposure-adjusted rate of moderate and severe exacerbations. Results: In the Spain cohort, the exposure-adjusted rate of on-treatment moderate/severe COPD exacerbations per year for FF/UMEC/VI was 1.31 versus 1.43 and 1.57 for FF/VI and UMEC/VI, respectively. No new adverse events were identified. The results are consistent with those observed in the overall ITT study population. Conclusion: In the Spain cohort of the IMPACT study, patients receiving triple therapy with FF/UMEC/VI had a lower exposure-adjusted rate of exacerbations compared with FF/VI and UMEC/VI, similar to the overall population. Study Title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease URL : https://www.clinicaltrialsregister.eu/ctr-search/search?query=CTT116855/ https://clinicaltrials.gov/ct2/show/NCT02164513 Registration number : GSK (CTT116855/NCT02164513). The reviews of this paper are available via the supplemental material section.