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Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study.
Chest. 2014 May; 145(5):981-991.Chest

Abstract

BACKGROUND

Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease (COPD).

OBJECTIVES

To compare the efficacy and safety of once-daily umeclidinium/vilanterol (UMEC/VI) 125/25 mcg with placebo and UMEC or VI monotherapy in COPD.

METHODS

This was a double-blind, placebo-controlled, parallel-group study. A total of 1493 patients were randomized (3:3:3:2) to 24 weeks of treatment with UMEC/VI 125/25 mcg, UMEC 125 mcg, VI 25 mcg, or placebo once-daily via dry powder inhaler.

RESULTS

Primary efficacy 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 also assessed. Safety evaluations included: adverse events, vital signs, electrocardiography and clinical laboratory measurements. All active treatments significantly improved trough FEV1 vs placebo (0.124-0.238 L, all p<0.001). Improvements with UMEC/VI 125/25 mcg were significantly greater than for UMEC 125 mcg or VI 25 mcg (0.079 L and 0.114 L; both p≤0.001). Improvements for UMEC/VI 125/25 mcg vs placebo were observed for the transition dyspnea index (1.0 unit; p<0.001), rescue albuterol use at Weeks 1-24 (-1.5 puffs/day) and St. George's Respiratory Questionnaire (-3.60 units, p<0.001). No safety signals were observed.

CONCLUSIONS

Once-daily UMEC/VI 125/25 mcg was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks. This study supports the use of UMEC/VI 125/25 mcg for the maintenance treatment of COPD.

CLINICAL TRIAL REGISTRATION

protocol number: DB2113361; ClinicalTrials.gov identifier: NCT01313637.

Authors+Show Affiliations

Brigham and Women's Hospital, Boston, MA. Electronic address: BCelli@copdnet.org.Medical Division, GlaxoSmithKline, Mississauga, ON, Canada.GlaxoSmithKline, Stockley Park, Uxbridge, England.Respiratory, GlaxoSmithKline, Research Triangle Park, NC.GlaxoSmithKline, Stockley Park, Uxbridge, England.Respiratory, GlaxoSmithKline, Research Triangle Park, NC.Respiratory, GlaxoSmithKline, Research Triangle Park, NC.

Pub Type(s)

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

Language

eng

PubMed ID

24385182

Citation

Celli, Bartolome, et al. "Once-daily Umeclidinium/vilanterol 125/25 Mcg in COPD: a Randomized, Controlled Study." Chest, vol. 145, no. 5, 2014, pp. 981-991.
Celli B, Crater G, Kilbride S, et al. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014;145(5):981-991.
Celli, B., Crater, G., Kilbride, S., Mehta, R., Tabberer, M., Kalberg, C. J., & Church, A. (2014). Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest, 145(5), 981-991. https://doi.org/10.1378/chest.13-1579
Celli B, et al. Once-daily Umeclidinium/vilanterol 125/25 Mcg in COPD: a Randomized, Controlled Study. Chest. 2014;145(5):981-991. PubMed PMID: 24385182.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. AU - Celli,Bartolome, AU - Crater,Glenn, AU - Kilbride,Sally, AU - Mehta,Rashmi, AU - Tabberer,Maggie, AU - Kalberg,Chris J, AU - Church,Alison, PY - 2014/1/4/entrez PY - 2014/1/5/pubmed PY - 2015/10/23/medline SP - 981 EP - 991 JF - Chest JO - Chest VL - 145 IS - 5 N2 - BACKGROUND: Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease (COPD). OBJECTIVES: To compare the efficacy and safety of once-daily umeclidinium/vilanterol (UMEC/VI) 125/25 mcg with placebo and UMEC or VI monotherapy in COPD. METHODS: This was a double-blind, placebo-controlled, parallel-group study. A total of 1493 patients were randomized (3:3:3:2) to 24 weeks of treatment with UMEC/VI 125/25 mcg, UMEC 125 mcg, VI 25 mcg, or placebo once-daily via dry powder inhaler. RESULTS: Primary efficacy 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 also assessed. Safety evaluations included: adverse events, vital signs, electrocardiography and clinical laboratory measurements. All active treatments significantly improved trough FEV1 vs placebo (0.124-0.238 L, all p<0.001). Improvements with UMEC/VI 125/25 mcg were significantly greater than for UMEC 125 mcg or VI 25 mcg (0.079 L and 0.114 L; both p≤0.001). Improvements for UMEC/VI 125/25 mcg vs placebo were observed for the transition dyspnea index (1.0 unit; p<0.001), rescue albuterol use at Weeks 1-24 (-1.5 puffs/day) and St. George's Respiratory Questionnaire (-3.60 units, p<0.001). No safety signals were observed. CONCLUSIONS: Once-daily UMEC/VI 125/25 mcg was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks. This study supports the use of UMEC/VI 125/25 mcg for the maintenance treatment of COPD. CLINICAL TRIAL REGISTRATION: protocol number: DB2113361; ClinicalTrials.gov identifier: NCT01313637. SN - 1931-3543 UR - https://www.unboundmedicine.com/medline/citation/24385182/Once_daily_umeclidinium/vilanterol_125/25_mcg_in_COPD:_a_randomized_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)34589-X DB - PRIME DP - Unbound Medicine ER -