At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids.
In Brief
A Phase 2 clinical trial evaluating CHF 5259 12.5 µg + Qvar and CHF 5259 placebo + Qvar for Asthma. Completed, enrolled 98 participants across 28 sites in 5 countries.
Detailed Summary
Primary objective The primary objective was to evaluate the superiority of CHF 5259 (glycopyrronium bromide \[GB\]) in a pressurised metered dose inhaler (pMDI) (50 μg total daily dose) versus placebo 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 superiority of CHF 5259 pMDI (50 μg total daily dose) versus placebo in terms of peak FEV1 on Day 42. Secondary objectives The secondary objectives were: * To evaluate the effect of CHF 5259 pMDI on other lung function parameters and on clinical outcome measures; * To assess the safety and tolerability of study medications.
Study Details
Timeline
Interventions
comparison of CHF 5259 versus placebo over 2 treatment periods of 6 weeks ± 2 days
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks ± 2 days