Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort

Summary

This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.

Timeline

Start

2015-10-13

Primary completion

2017-05-04

Completion

2017-05-04

Outcome

Met primary endpoint

registry analysis (superiority test); QVA149 110/50 Micrograms vs Salmeterol/Fluticasone 50/500 Micrograms; p = 0.028; Mean Difference (Final Values) 0.045 (95% CI 0.005 to 0.084) NCT02516592 ↗

Publications

• Frith PA, Ashmawi S, Krishnamurthy S, Gurgun A, Hristoskova S, Pilipovic V, Hamann AM, Backer A, Olsson P, Kostikas K, Diaz DV; FLASH Investigators. Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial. Respirology. 2018 Dec;23(12):1152-1159. doi: 10.1111/resp.13374. Epub 2018 Aug 3.

Drugs

Indications