drugset / Trial / NCT03137784

Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma

NCT03137784 ↗

Phase 2/3 Completed 148 enrolled Novartis Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients

Timeline

Start
2017-05-04
Primary completion
2017-12-29
Completion
2017-12-29

Outcome

Met primary endpoint

registry analysis (other test); NVA237 50 ug vs Placebo; p <0.001; Linear Mixed Model (LMM) 0.089 (95% CI 0.047 to 0.132); Linear Mixed Model NCT03137784 ↗

registry analysis (other test); NVA237 25 ug vs Placebo; p <0.001; Linear Mixed Model (LMM) 0.090 (95% CI 0.047 to 0.132); Linear Mixed Model NCT03137784 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrrolate Small molecule 25 ug —
Subject Glycopyrrolate Small molecule 50 ug —

Indications