NCT04259164

Anti-inflammatory Effects Glycopyrronium

Evaluation of the Anti-inflammatory Effects of Glycopyrronium Added to Indacaterol/Mometasone on the Allergen-induced Late Asthmatic Response

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Allergic Asthma

Interventions

Type	Name	Description
DRUG	QVM149	Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol
DRUG	QMF149	Mometasone / Indacaterol

Timeline

• Start date: 2020-09-10
• Primary completion: 2022-12-29
• Completion: 2022-12-29
• First posted: 2020-02-06
• Last updated: 2023-01-12

Locations

1 site across 1 country: Netherlands