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Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.
Drugs R D. 2016 Jun; 16(2):217-27.DR

Abstract

INTRODUCTION

The fixed-dose, long-acting bronchodilator combination of umeclidinium/vilanterol (UMEC/VI) has not previously been compared with a combination of a long-acting muscarinic antagonist and long-acting β2-agonist in patients with chronic obstructive pulmonary disease (COPD).

METHODS

This 12-week, randomized, blinded, triple-dummy, parallel-group, non-inferiority study compared once-daily UMEC/VI 62.5/25 mcg with once-daily tiotropium (TIO) 18 mcg + indacaterol (IND) 150 mcg in patients with moderate-to-very-severe COPD. The primary endpoint was the trough forced expiratory volume in 1 s (FEV1) on day 85 (predefined non-inferiority margin -50 mL), and the secondary endpoint was the 0- to 6-h weighted mean (WM) FEV1 on day 84. Other efficacy endpoints [including rescue medication use, the Transition Dyspnea Index (TDI) focal score, and the St. George's Respiratory Questionnaire (SGRQ) score] and safety endpoints [adverse events (AEs), vital signs, and COPD exacerbations] were also assessed.

RESULTS

Trough FEV1 improvements were comparable between treatment groups [least squares (LS) mean changes from baseline to day 85: UMEC/VI 172 mL; TIO + IND 171 mL; treatment difference 1 mL; 95 % confidence interval (CI) -29 to 30 mL], demonstrating non-inferiority between UMEC/VI and TIO + IND. The treatments produced similar improvements in the trough FEV1 at other study visits and the 0- to 6-h WM FEV1 (LS mean changes at day 84: UMEC/VI 235 mL; TIO + IND 258 mL; treatment difference -23 mL; 95 % CI -54 to 8 mL). The results for patient-reported measures (rescue medication use, TDI focal score, and SGRQ score) were comparable; both treatments produced clinically meaningful improvements in TDI and SGRQ scores. The incidence of AEs and COPD exacerbations, and changes in vital signs were similar for the two treatments.

CONCLUSION

UMEC/VI and TIO + IND, given once daily, provided similar improvements in lung function and patient-reported outcomes over 12 weeks in patients with COPD, with comparable tolerability and safety profiles.

TRIAL NUMBERS

ClinicalTrials.gov study ID NCT02257385; GSK study no. 116961.

Authors+Show Affiliations

GSK, PO Box 13398, Research Triangle Park, NC, 27709-3398, USA. chris.j.kalberg@gsk.com.GSK, PO Box 13398, Research Triangle Park, NC, 27709-3398, USA.GSK, PO Box 13398, Research Triangle Park, NC, 27709-3398, USA.Respiratory Medicines Development Centre, GSK, Stockley Park, Middlesex, UK.Respiratory Medicines Development Centre, GSK, Stockley Park, Middlesex, UK.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27028749

Citation

Kalberg, Chris, et al. "Dual Bronchodilator Therapy With Umeclidinium/Vilanterol Versus Tiotropium Plus Indacaterol in Chronic Obstructive Pulmonary Disease: a Randomized Controlled Trial." Drugs in R&D, vol. 16, no. 2, 2016, pp. 217-27.
Kalberg C, O'Dell D, Galkin D, et al. Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Drugs R D. 2016;16(2):217-27.
Kalberg, C., O'Dell, D., Galkin, D., Newlands, A., & Fahy, W. A. (2016). Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Drugs in R&D, 16(2), 217-27. https://doi.org/10.1007/s40268-016-0131-2
Kalberg C, et al. Dual Bronchodilator Therapy With Umeclidinium/Vilanterol Versus Tiotropium Plus Indacaterol in Chronic Obstructive Pulmonary Disease: a Randomized Controlled Trial. Drugs R D. 2016;16(2):217-27. PubMed PMID: 27028749.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. AU - Kalberg,Chris, AU - O'Dell,Dianne, AU - Galkin,Dmitry, AU - Newlands,Amy, AU - Fahy,William A, PY - 2016/3/31/entrez PY - 2016/3/31/pubmed PY - 2017/5/2/medline SP - 217 EP - 27 JF - Drugs in R&D JO - Drugs R D VL - 16 IS - 2 N2 - INTRODUCTION: The fixed-dose, long-acting bronchodilator combination of umeclidinium/vilanterol (UMEC/VI) has not previously been compared with a combination of a long-acting muscarinic antagonist and long-acting β2-agonist in patients with chronic obstructive pulmonary disease (COPD). METHODS: This 12-week, randomized, blinded, triple-dummy, parallel-group, non-inferiority study compared once-daily UMEC/VI 62.5/25 mcg with once-daily tiotropium (TIO) 18 mcg + indacaterol (IND) 150 mcg in patients with moderate-to-very-severe COPD. The primary endpoint was the trough forced expiratory volume in 1 s (FEV1) on day 85 (predefined non-inferiority margin -50 mL), and the secondary endpoint was the 0- to 6-h weighted mean (WM) FEV1 on day 84. Other efficacy endpoints [including rescue medication use, the Transition Dyspnea Index (TDI) focal score, and the St. George's Respiratory Questionnaire (SGRQ) score] and safety endpoints [adverse events (AEs), vital signs, and COPD exacerbations] were also assessed. RESULTS: Trough FEV1 improvements were comparable between treatment groups [least squares (LS) mean changes from baseline to day 85: UMEC/VI 172 mL; TIO + IND 171 mL; treatment difference 1 mL; 95 % confidence interval (CI) -29 to 30 mL], demonstrating non-inferiority between UMEC/VI and TIO + IND. The treatments produced similar improvements in the trough FEV1 at other study visits and the 0- to 6-h WM FEV1 (LS mean changes at day 84: UMEC/VI 235 mL; TIO + IND 258 mL; treatment difference -23 mL; 95 % CI -54 to 8 mL). The results for patient-reported measures (rescue medication use, TDI focal score, and SGRQ score) were comparable; both treatments produced clinically meaningful improvements in TDI and SGRQ scores. The incidence of AEs and COPD exacerbations, and changes in vital signs were similar for the two treatments. CONCLUSION: UMEC/VI and TIO + IND, given once daily, provided similar improvements in lung function and patient-reported outcomes over 12 weeks in patients with COPD, with comparable tolerability and safety profiles. TRIAL NUMBERS: ClinicalTrials.gov study ID NCT02257385; GSK study no. 116961. SN - 1179-6901 UR - https://www.unboundmedicine.com/medline/citation/27028749/Dual_Bronchodilator_Therapy_with_Umeclidinium/Vilanterol_Versus_Tiotropium_plus_Indacaterol_in_Chronic_Obstructive_Pulmonary_Disease:_A_Randomized_Controlled_Trial_ L2 - https://dx.doi.org/10.1007/s40268-016-0131-2 DB - PRIME DP - Unbound Medicine ER -