drugset / Trial / NCT06545500
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
RandomizedCrossoverTriple-blindTreatment
Summary
This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2024-08-16
- Primary completion
- 2025-01-02
- Completion
- 2025-01-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 14 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 42.5 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 85 ug | Inhaled |