drugset / Trial / NCT04259164
Anti-inflammatory Effects Glycopyrronium
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrronium | Unknown | 50 ug | — |
| Background | Indacaterol | Other / unclassified | 150 ug | — |
| Background | Mometasone | Other / unclassified | 80 ug | — |
| Background | Mometasone | Other / unclassified | 160 ug | — |