Conditions: Chronic Obstructive Pulmonary Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 66
Healthy volunteers: no

Brief summary:
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

Detailed description:
This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of GP MDI (28.8, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate to severe COPD.

Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as specified in the protocol. To allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of Treatment Period 1).

The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID. Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC, CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter represented 1 of the 4 treatments included in the study by random assignment.

Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each Treatment Period separated by a washout period of 5 to 21 days.

Arms:
arm 1: Glycopyrronium Metered Dose Inhaler 28.8 micrograms arm 2: Glycopyrronium Metered Dose Inhaler 14.4 micrograms arm 3: Glycopyrronium Metered Dose Inhaler 7.2 micrograms arm 4: Placebo Inhalation Aerosol

Interventions: intervention 1: Glycopyrronium MDI 28.8 micrograms intervention 2: Glycopyrronium MDI 14.4 micrograms intervention 3: Glycopyrronium MDI 7.2 micrograms intervention 4: Placebo MDI
Intervention descriptions: intervention 1: Glycopyrronium MDI 28.8 micrograms intervention 2: Glycopyrronium MDI 14.4 micrograms intervention 3: Glycopyrronium MDI 7.2 micrograms intervention 4: Placebo Inhalation Aerosol

Protocol document: