Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic bronchitis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 42
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily arm 5: Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily arm 6: Placebo 0.5mL via e-flow nebulizer, once daily

Interventions: intervention 1: Glycopyrrolate Inhalation Solution12.5μg intervention 2: Glycopyrrolate Inhalation Solution 50μg intervention 3: Glycopyrrolate Inhalation Solution 100μg intervention 4: Glycopyrrolate Inhalation Solution 200μg intervention 5: Glycopyrrolate Inhalation Solution 400μg intervention 6: Placebo 0.5mL
Intervention descriptions: intervention 1: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily intervention 2: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily intervention 3: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily intervention 4: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily intervention 5: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily intervention 6: Placebo 0.5mL via eFlow, once daily

Protocol document: