Trials / Completed
CompletedNCT02948582
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)
Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Sunovion Respiratory Development Inc. · Industry
- Sex
- —
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glycopyrrolate Inhalation Solution12.5μg | Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily |
| DRUG | Glycopyrrolate Inhalation Solution 50μg | Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily |
| DRUG | Glycopyrrolate Inhalation Solution 100μg | Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily |
| DRUG | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| DRUG | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| DRUG | Placebo 0.5mL | Placebo 0.5mL via eFlow, once daily |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2016-10-28
- Last updated
- 2018-03-12
- Results posted
- 2018-03-12
Source: ClinicalTrials.gov record NCT02948582. Inclusion in this directory is not an endorsement.