Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Summary
The study assessed the safety and ability of an orally inhaled medicine \[i.e., Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.
Timeline
- Start
- 2010-07
- Primary completion
- 2010-11
- Completion
- 2010-11
Outcome
Met primary endpoint
registry analysis (superiority test); Glycopyrrolate Inhalation Solution 50μg vs Placebo 0.5mL; p = 0.0008; least squares mean 0.072 (95% CI 0.030 to 0.113); NCT02948582 ↗
registry analysis (superiority test); Glycopyrrolate Inhalation Solution 100μg vs Placebo 0.5mL; p <0.0001; least squares mean 0.156 (95% CI 0.120 to 0.193); NCT02948582 ↗
registry analysis (superiority test); Glycopyrrolate Inhalation Solution 200μg vs Placebo 0.5mL; p <0.0001; least squares mean 0.135 (95% CI 0.098 to 0.173); NCT02948582 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 12.5 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 50 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 100 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 200 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 400 ug | Inhaled |