drugset / Trial / NCT01176903
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.
Timeline
- Start
- 2010-08
- Primary completion
- 2010-11
- Completion
- 2011-08
Outcome
Met primary endpoint
paper on Day 7 (primary) were 115, 142 and 136 mL for GB 12.5, 25 and 50 μg BID, respectively (all P<0.001). PMID 28744115 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 12.5 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 25 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 50 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 100 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 200 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 18 ug | Inhaled |