Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD.
Respir Med 2013; 107(10):1538-46RM

Abstract

STUDY OBJECTIVE

To examine the efficacy and safety of the once-daily, inhaled, long-acting muscarinic antagonist/β2-agonist combination umeclidinium/vilanterol (UMEC/VI) compared with UMEC and VI monotherapies in patients with chronic obstructive pulmonary disease (COPD).

METHODS

In this 24-week, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov: NCT01313650) eligible patients were randomised 3:3:3:2 to treatment with UMEC/VI 62.5/25 mcg, UMEC 62.5 mcg, VI 25 mcg or placebo administered once daily via dry powder inhaler (N = 1532; intent-to-treat population). Primary endpoint was trough forced expiratory volume in one second (FEV1) on Day 169 (23-24 h post-dose). Additional lung-function, symptomatic, and health-related quality-of-life endpoints were assessed, including 0-6 h weighted-mean FEV1, rescue salbutamol use, Transition Dyspnoea Index (TDI), Shortness Of Breath With Daily Activity (SOBDA) and St. George's Respiratory Questionnaire (SGRQ) scores. Safety evaluations included adverse events (AEs), vital signs, 12-lead/24-h Holter electrocardiography parameters and clinical laboratory/haematology measurements.

RESULTS

All active treatments produced statistically significant improvements in trough FEV1 compared with placebo on Day 169 (0.072-0.167 L, all p < 0.001); increases with UMEC/VI 62.5/25 mcg were significantly greater than monotherapies (0.052-0.095 L, p ≤ 0.004). Improvements were observed for UMEC/VI 62.5/25 mcg vs placebo for weighted-mean FEV1 on Day 168 (0.242 L, p < 0.001), rescue salbutamol use during Weeks 1-24 (-0.8 puffs/day, p = 0.001), TDI (1.2 units, p < 0.001), SOBDA (-0.17 units, p < 0.001) and SGRQ (-5.51 units, p < 0.001) scores. No clinically-significant changes in vital signs, electrocardiography, or laboratory parameters were observed.

CONCLUSION

Once-daily UMEC/VI 62.5/25 mcg was well tolerated and provided clinically-significant improvements in lung function and symptoms in patients with COPD.

Authors+Show Affiliations

Department of Medicine, 111 Mason Farm Road, University of North Carolina College of Medicine, Chapel Hill, NC 27599, USA. Electronic address: james_donohue@med.unc.edu.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23830094

Citation

Donohue, J F., et al. "Efficacy and Safety of Once-daily Umeclidinium/vilanterol 62.5/25 Mcg in COPD." Respiratory Medicine, vol. 107, no. 10, 2013, pp. 1538-46.
Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013;107(10):1538-46.
Donohue, J. F., Maleki-Yazdi, M. R., Kilbride, S., Mehta, R., Kalberg, C., & Church, A. (2013). Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respiratory Medicine, 107(10), pp. 1538-46. doi:10.1016/j.rmed.2013.06.001.
Donohue JF, et al. Efficacy and Safety of Once-daily Umeclidinium/vilanterol 62.5/25 Mcg in COPD. Respir Med. 2013;107(10):1538-46. PubMed PMID: 23830094.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. AU - Donohue,J F, AU - Maleki-Yazdi,M R, AU - Kilbride,S, AU - Mehta,R, AU - Kalberg,C, AU - Church,A, Y1 - 2013/07/02/ PY - 2013/03/28/received PY - 2013/05/30/revised PY - 2013/06/02/accepted PY - 2013/7/9/entrez PY - 2013/7/9/pubmed PY - 2014/5/14/medline KW - COPD KW - Fixed-dose combination KW - Long-acting bronchodilator KW - Muscarinic antagonist KW - Randomised KW - β-agonist SP - 1538 EP - 46 JF - Respiratory medicine JO - Respir Med VL - 107 IS - 10 N2 - STUDY OBJECTIVE: To examine the efficacy and safety of the once-daily, inhaled, long-acting muscarinic antagonist/β2-agonist combination umeclidinium/vilanterol (UMEC/VI) compared with UMEC and VI monotherapies in patients with chronic obstructive pulmonary disease (COPD). METHODS: In this 24-week, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov: NCT01313650) eligible patients were randomised 3:3:3:2 to treatment with UMEC/VI 62.5/25 mcg, UMEC 62.5 mcg, VI 25 mcg or placebo administered once daily via dry powder inhaler (N = 1532; intent-to-treat population). Primary endpoint was trough forced expiratory volume in one second (FEV1) on Day 169 (23-24 h post-dose). Additional lung-function, symptomatic, and health-related quality-of-life endpoints were assessed, including 0-6 h weighted-mean FEV1, rescue salbutamol use, Transition Dyspnoea Index (TDI), Shortness Of Breath With Daily Activity (SOBDA) and St. George's Respiratory Questionnaire (SGRQ) scores. Safety evaluations included adverse events (AEs), vital signs, 12-lead/24-h Holter electrocardiography parameters and clinical laboratory/haematology measurements. RESULTS: All active treatments produced statistically significant improvements in trough FEV1 compared with placebo on Day 169 (0.072-0.167 L, all p < 0.001); increases with UMEC/VI 62.5/25 mcg were significantly greater than monotherapies (0.052-0.095 L, p ≤ 0.004). Improvements were observed for UMEC/VI 62.5/25 mcg vs placebo for weighted-mean FEV1 on Day 168 (0.242 L, p < 0.001), rescue salbutamol use during Weeks 1-24 (-0.8 puffs/day, p = 0.001), TDI (1.2 units, p < 0.001), SOBDA (-0.17 units, p < 0.001) and SGRQ (-5.51 units, p < 0.001) scores. No clinically-significant changes in vital signs, electrocardiography, or laboratory parameters were observed. CONCLUSION: Once-daily UMEC/VI 62.5/25 mcg was well tolerated and provided clinically-significant improvements in lung function and symptoms in patients with COPD. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/23830094/Efficacy_and_safety_of_once_daily_umeclidinium/vilanterol_62_5/25_mcg_in_COPD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(13)00213-8 DB - PRIME DP - Unbound Medicine ER -