drugset / Trial / NCT04259164

Anti-inflammatory Effects Glycopyrronium

NCT04259164

RandomizedCrossoverTriple-blindTreatment

Summary

Double-blind, randomized, two-way cross-over study with two treatment periods. 28 subjects with asthma will be randomized in 1:1 ratio to treatment A) Indacaterol/Mometasone 150/160 μg once daily and treatment B) Indacaterol/Glycopyrronium/Mometasone 150/50/80 μg once daily for period 1. For period 2, subjects will be crossed over to the other treatment arm. Subjects will be screened during the first visit. After inclusion subjects will be seen for 3 visits during the Run-in period, 3 visits during treatment period 1 and 3 visits during treatment period 2. During these visits patients will be clinically characterized and exposed to allergen challenge tests.

Timeline

Start
2020-09-10
Primary completion
2022-12-29
Completion
2022-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrronium Unknown 50 ug
Background Indacaterol Other / unclassified 150 ug
Background Mometasone Other / unclassified 80 ug
Background Mometasone Other / unclassified 160 ug

Indications