drugset
drugset / Trial / NCT02127866

Triple in Asthma Dose Finding

NCT02127866 ↗

Phase 2 Completed 211 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverQuadruple-blindTreatment

Summary

Primary objective The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in the first second (FEV1) area under the curve between time 0 and 12 hours (AUC0-12h) normalised by time on Day 42. Key secondary objective The key secondary objective was to evaluate the efficacy of the free combination CHF 5259 plus Foster® 100/6 μg by comparison with Foster® 100/6 μg in terms of peak FEV1 on Day 42. Secondary objectives The secondary objectives were: * To evaluate the effect of the free combination of CHF 5259 plus Foster® 100/6 μg on other lung function parameters and on clinical outcome measures; * To assess the safety and the tolerability of the study treatments.

Timeline

Start
2014-04-11
Primary completion
2015-03-08
Completion
2015-03-08

Outcome

Met primary endpoint

registry analysis (superiority test); Treatment A - ITT vs Treatment D - ITT; p <0.001; adjusted mean difference 0.059 (95% CI 0.021 to 0.096) NCT02127866 ↗

registry analysis (superiority test); Treatment B - ITT vs Treatment D - ITT; p <0.001; adjusted mean difference 0.084 (95% CI 0.047 to 0.121) NCT02127866 ↗

registry analysis (superiority test); Treatment C - ITT vs Treatment D - ITT; p <0.001; adjusted mean difference 0.084 (95% CI 0.047 to 0.121) NCT02127866 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Foster Unknown 24 ug Inhaled
Subject Foster Unknown 400 ug Inhaled
Subject Glycopyrrolate Small molecule 25 ug Inhaled
Subject Glycopyrrolate Small molecule 50 ug Inhaled
Subject Glycopyrrolate Small molecule 100 ug Inhaled

Indications

asthma