Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Emphysema Chronic bronchitis COPD Chronic Obstructive Pulmonary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
The study assessed the safety and ability of several doses of an orally inhaled medicine \[ie, Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.

Detailed description:
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.

Arms:
arm 1: Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily arm 5: Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily arm 6: Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily arm 7: Placebo 0.5 mL via jet nebulizer, once daily

Interventions: intervention 1: Glycopyrrolate Inhalation Solution 25mg intervention 2: Glycopyrrolate Inhalation Solution 75mg intervention 3: Glycopyrrolate Inhalation Solution 200mg intervention 4: Glycopyrrolate Inhalation Solution 200mg Jet intervention 5: Glycopyrrolate Inhalation Solution 500mg intervention 6: Glycopyrrolate Inhalation Solution1000mg intervention 7: Placebo
Intervention descriptions: intervention 1: 25 μg oral inhalation via eFlow Nebulizer, once daily intervention 2: 75 μg oral inhalation via eFlow Nebulizer, once daily intervention 3: 200 μg oral inhalation via eFlow Nebulizer, once daily intervention 4: 200 μg oral inhalation via inhalation via jet nebulizer, once daily intervention 5: 500 μg oral inhalation via eFlow nebulizer, once daily intervention 6: 1000 μg oral inhalation via eFlow nebulizer, once daily intervention 7: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Protocol document: