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Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.
Lung. 2017 12; 195(6):739-747.LUNG

Abstract

PURPOSE

To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI).

METHODS

Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62.5/25 μg, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV1 AUC0-24). Rescue medication use, symptom control, and safety were assessed throughout.

RESULTS

Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV1 AUC0-24h at week 12 of 232 and 185 mL for IND/GLY, and 244 and 203 mL with UMEC/VI in Studies A2349 and A2350, respectively. The primary efficacy objective of non-inferiority of IND/GLY relative to UMEC/VI was not met as the lower bound of the confidence interval for the LS treatment comparison was below the pre-specified non-inferiority margin of -20 mL in both studies: -26.9 and -34.2 mL, respectively (LS mean between-treatment differences: -11.5 and -18.2 mL). Both drugs were well tolerated, with AE profiles consistent with their respective prescribing information.

CONCLUSIONS

IND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498).

Authors+Show Affiliations

Clinical Research Institute, Medford, OR, USA.Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA.Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Healthcare Pvt. Ltd., Hyderabad, India.Novartis Healthcare Pvt. Ltd., Hyderabad, India.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. donald.banerji@novartis.com.

Pub Type(s)

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

Language

eng

PubMed ID

28993871

Citation

Kerwin, Edward, et al. "Dual Bronchodilation With Indacaterol Maleate/Glycopyrronium Bromide Compared With Umeclidinium Bromide/Vilanterol in Patients With Moderate-to-Severe COPD: Results From Two Randomized, Controlled, Cross-over Studies." Lung, vol. 195, no. 6, 2017, pp. 739-747.
Kerwin E, Ferguson GT, Sanjar S, et al. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017;195(6):739-747.
Kerwin, E., Ferguson, G. T., Sanjar, S., Goodin, T., Yadao, A., Fogel, R., Maitra, S., Sen, B., Ayers, T., & Banerji, D. (2017). Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung, 195(6), 739-747. https://doi.org/10.1007/s00408-017-0055-9
Kerwin E, et al. Dual Bronchodilation With Indacaterol Maleate/Glycopyrronium Bromide Compared With Umeclidinium Bromide/Vilanterol in Patients With Moderate-to-Severe COPD: Results From Two Randomized, Controlled, Cross-over Studies. Lung. 2017;195(6):739-747. PubMed PMID: 28993871.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. AU - Kerwin,Edward, AU - Ferguson,Gary T, AU - Sanjar,Shahin, AU - Goodin,Thomas, AU - Yadao,Anthony, AU - Fogel,Robert, AU - Maitra,Samopriyo, AU - Sen,Biswajit, AU - Ayers,Tim, AU - Banerji,Donald, Y1 - 2017/10/09/ PY - 2017/07/31/received PY - 2017/09/11/accepted PY - 2017/10/11/pubmed PY - 2018/7/7/medline PY - 2017/10/11/entrez KW - COPD KW - Indacaterol/glycopyrrolate KW - Long-acting muscarinic antagonist KW - Long-acting β2-agonists KW - Non-inferiority trial KW - Umeclidinium/vilanterol SP - 739 EP - 747 JF - Lung JO - Lung VL - 195 IS - 6 N2 - PURPOSE: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI). METHODS: Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62.5/25 μg, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV1 AUC0-24). Rescue medication use, symptom control, and safety were assessed throughout. RESULTS: Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV1 AUC0-24h at week 12 of 232 and 185 mL for IND/GLY, and 244 and 203 mL with UMEC/VI in Studies A2349 and A2350, respectively. The primary efficacy objective of non-inferiority of IND/GLY relative to UMEC/VI was not met as the lower bound of the confidence interval for the LS treatment comparison was below the pre-specified non-inferiority margin of -20 mL in both studies: -26.9 and -34.2 mL, respectively (LS mean between-treatment differences: -11.5 and -18.2 mL). Both drugs were well tolerated, with AE profiles consistent with their respective prescribing information. CONCLUSIONS: IND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498). SN - 1432-1750 UR - https://www.unboundmedicine.com/medline/citation/28993871/Dual_Bronchodilation_with_Indacaterol_Maleate/Glycopyrronium_Bromide_Compared_with_Umeclidinium_Bromide/Vilanterol_in_Patients_with_Moderate_to_Severe_COPD:_Results_from_Two_Randomized_Controlled_Cross_over_Studies_ L2 - https://dx.doi.org/10.1007/s00408-017-0055-9 DB - PRIME DP - Unbound Medicine ER -