Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)
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.
Timeline
- Start
- 2014-11-21
- Primary completion
- 2015-08-13
- Completion
- 2015-08-13
Outcome
Met primary endpoint
registry analysis (superiority test); CHF5259 pMDI - ITT vs Placebo pMDI - ITT; p <0.001; adjusted mean difference 0.135 (95% CI 0.092 to 0.177); ANCOVA NCT02296411 ↗
registry analysis (superiority test); CHF5259 pMDI vs Placebo pMDI; p <0.001; adjusted mean difference 0.128 (95% CI 0.082 to 0.174); ANCOVA NCT02296411 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 12.5 ug | Inhaled |
| Background | beclomethasone dipropionate | Other / unclassified | 50 ug | Inhaled |
| Background | beclomethasone dipropionate | Other / unclassified | 100 ug | Inhaled |