Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Japan COPD CAT placebo serum Adoair250 anti-inflammatory sputum
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.

Detailed description:
This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.

At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.

* ADOAIR®250 one inhalation twice daily from the DISKUS inhaler
* Placebo one inhalation twice daily from the DISKUS inhaler

Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).

Arms:
arm 1: ADOAIR 250mcg inhalations, twice daily, from week0 - 12 arm 2: Placebo inhalation, twice daily, from week0 -12

Interventions: intervention 1: ADOAIR250 intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mcg inhalation, twice daily, from week0 -12. intervention 2: Placebo inhalation, twice daily, from week0 -12.

Protocol document: