Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week
parallel group study evaluating the effects of once daily in the morning treatment of FF/VI
Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on
lung function in COPD subjects.
Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to
evaluate the subject's adherence with study treatment, study procedures and assessment of
disease stability.
At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the
Randomization Criteria will be randomized to double-blind study medication (12-week treatment
period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone
Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in
NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1
inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening
(approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study
medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return
to the clinic at the end of the treatment period.
A follow-up phone contact will be performed approximately 7 days after the last clinic visit.
The overall study duration (Screening to Follow-up) for each subject is approximately 15
weeks.
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