Abstract | INTRODUCTION: METHODS: The 24-week EMAX trial evaluated lung function, symptoms, health status, exacerbations, clinically important deterioration, and safety with umeclidinium/ vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving ICS. Current and former smoker subgroups were defined by smoking status at screening. RESULTS: The analysis included 1203 (50%) current smokers and 1221 (50%) former smokers. Both subgroups demonstrated greater improvements from baseline in trough FEV1 at week 24 (primary endpoint) with umeclidinium/ vilanterol versus umeclidinium (least squares [LS] mean difference, mL [95% CI]; current: 84 [50, 117]; former: 49 [18, 80]) and salmeterol (current: 165 [132, 198]; former: 117 [86, 148]) and larger reductions in rescue medication inhalations/day over 24 weeks versus umeclidinium (LS mean difference [95% CI]; current: - 0.42 [- 0.63, - 0.20]; former: - 0.25 - 0.44, - 0.05]) and salmeterol (current: - 0.28 [- 0.49, - 0.06]; former: - 0.29 [- 0.49, - 0.09]). Umeclidinium/ vilanterol increased the odds (odds ratio [95% CI]) of clinically significant improvement at week 24 in Transition Dyspnea Index versus umeclidinium (current: 1.54 [1.16, 2.06]; former: 1.32 [0.99, 1.75]) and salmeterol (current: 1.37 (1.03, 1.82]; former: 1.60 [1.20, 2.13]) and Evaluating Respiratory Symptoms- COPD versus umeclidinium (current: 1.54 [1.13, 2.09]; former: 1.50 [1.11, 2.04]) and salmeterol (current: 1.53 [1.13, 2.08]; former: 1.53 [1.12, 2.08]). All treatments were well tolerated in both subgroups. CONCLUSIONS:
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Authors | Leif H Bjermer, Isabelle H Boucot, Claus F Vogelmeier, François Maltais, Paul W Jones, Lee Tombs, Chris Compton, David A Lipson, Edward M Kerwin |
Journal | Advances in therapy
(Adv Ther)
Vol. 38
Issue 9
Pg. 4815-4835
(09 2021)
ISSN: 1865-8652 [Electronic] United States |
PMID | 34347255
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2021. The Author(s). |
Chemical References |
- Benzyl Alcohols
- Bronchodilator Agents
- Chlorobenzenes
- Drug Combinations
- GSK573719
- Quinuclidines
- vilanterol
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Topics |
- Administration, Inhalation
- Benzyl Alcohols
- Bronchodilator Agents
(therapeutic use)
- Chlorobenzenes
(therapeutic use)
- Double-Blind Method
- Drug Combinations
- Forced Expiratory Volume
- Humans
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
- Quinuclidines
(therapeutic use)
- Smokers
- Treatment Outcome
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