drugset / Trial / NCT02433834
Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
RandomizedCrossoverQuadruple-blindTreatment
Summary
A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
Timeline
- Start
- 2015-05-27
- Primary completion
- 2016-03-26
- Completion
- 2016-03-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrronium | Unknown | 1.9 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 3.6 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 7.2 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 14.4 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 28.8 ug | Inhaled |
| Comparator | salmeterol xinafoate | Unknown | 50 ug | Inhaled |