Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Chronic Dosing (7-Day), Four-Period, Four-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
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.
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.
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