Jump to main content
US EPA
United States Environmental Protection Agency
Search
Search
Main menu
Environmental Topics
Laws & Regulations
About EPA
Health & Environmental Research Online (HERO)
Contact Us
Print
Feedback
Export to File
Search:
This record has one attached file:
Add More Files
Attach File(s):
Display Name for File*:
Save
Citation
Tags
HERO ID
8453968
Reference Type
Journal Article
Title
Preventing Clinically Important Deterioration of COPD with Addition of Umeclidinium to Inhaled Corticosteroid/Long-Acting β2-Agonist Therapy: An Integrated Post Hoc Analysis
Author(s)
Naya, IP; Tombs, L; Lipson, DA; Compton, C
Year
2018
Is Peer Reviewed?
Yes
Journal
Advances in Therapy
ISSN:
0741-238X
EISSN:
1865-8652
Publisher
Springer Healthcare
Volume
35
Issue
10
Page Numbers
1626-1638
Language
English
DOI
10.1007/s12325-018-0771-4
Abstract
Introduction: Assessing clinically important measures of disease progression is essential for evaluating therapeutic effects on disease stability in chronic obstructive pulmonary disease (COPD). This analysis assessed whether providing additional bronchodilation with the long-acting muscarinic antagonist umeclidinium (UMEC) to patients treated with inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy would improve disease stability compared with ICS/LABA therapy alone. Methods: This integrated post hoc analysis of four 12-week, randomized, double-blind trials (NCT01772134, NCT01772147, NCT01957163, NCT02119286) compared UMEC 62.5 µg with placebo added to open-label ICS/LABA in symptomatic patients with COPD (modified Medical Research Council dyspnea scale score ⥠2). A clinically important deterioration (CID) was defined as: a decrease from baseline of ⥠100 mL in trough forced expiratory volume in 1 s (FEV1), an increase from baseline of ⥠4 units in St Georgeâs Respiratory Questionnaire (SGRQ) total score, or a moderate/severe exacerbation. Risk of a first CID was evaluated in the intent-to-treat (ITT) population and in patients stratified by Global initiative for chronic Obstructive Lung Disease (GOLD) classification, exacerbation history and type of ICS/LABA therapy. Adverse events (AEs) were also assessed. Results: Overall, 1637 patients included in the ITT population received UMEC + ICS/LABA (n = 819) or placebo + ICS/LABA (n = 818). Additional bronchodilation with UMEC reduced the risk of a first CID by 45â58% in the ITT population and all subgroups analyzed compared with placebo (all p < 0.001). Improvements were observed in reducing FEV1 (69% risk reduction; p < 0.001) and exacerbation (47% risk reduction; p = 0.004) events in the ITT population. No significant reduction in risk of a SGRQ CID was observed. AE incidence was similar between treatment groups. Conclusion: Symptomatic patients with COPD receiving ICS/LABA experience frequent deteriorations. Additional bronchodilation with UMEC significantly reduced the risk of CID and provided greater short-term stability versus continued ICS/LABA therapy in these patients. Funding: GlaxoSmithKline (study number: 202067). Plain Language Summary: Plain language summary available for this article. © 2018, The Author(s).
Keywords
Add-on LAMA; Clinically important deteriorations; COPD; Fluticasone furoate/vilanterol; Fluticasone propionate/salmeterol; Respiratory; Triple therapy; Umeclidinium
Home
Learn about HERO
Using HERO
Search HERO
Projects in HERO
Risk Assessment
Transparency & Integrity