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Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT.
- Source :
-
Therapeutic advances in respiratory disease [Ther Adv Respir Dis] 2020 Jan-Dec; Vol. 14, pp. 1753466620963021. - Publication Year :
- 2020
-
Abstract
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Administration, Inhalation
Adult
Aged
Aged, 80 and over
Androstadienes adverse effects
Benzyl Alcohols adverse effects
Bronchodilator Agents adverse effects
Chlorobenzenes adverse effects
Disease Progression
Double-Blind Method
Drug Combinations
Female
Glucocorticoids adverse effects
Humans
Lung physiopathology
Male
Middle Aged
Muscarinic Antagonists adverse effects
Nebulizers and Vaporizers
Pulmonary Disease, Chronic Obstructive diagnosis
Pulmonary Disease, Chronic Obstructive physiopathology
Quinuclidines adverse effects
Recovery of Function
Spain
Time Factors
Treatment Outcome
Androstadienes administration & dosage
Benzyl Alcohols administration & dosage
Bronchodilator Agents administration & dosage
Chlorobenzenes administration & dosage
Glucocorticoids administration & dosage
Lung drug effects
Muscarinic Antagonists administration & dosage
Pulmonary Disease, Chronic Obstructive drug therapy
Quinuclidines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1753-4666
- Volume :
- 14
- Database :
- MEDLINE
- Journal :
- Therapeutic advances in respiratory disease
- Publication Type :
- Academic Journal
- Accession number :
- 33121372
- Full Text :
- https://doi.org/10.1177/1753466620963021