Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Vilanterol (VI) Novel Dry Powder Inhaler (NDPI) FEV1 Fluticasone Furoate (FF) COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 828
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Subjects randomized to the FF/VI 100/25 arm will take an active inhalation of study medication during their morning dosing from their NDPI and will have an inhalation of dummy medication (placebo) as their morning ACCUHALER/DISKUS dose and as their evening dose. arm 2: Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg arm will have an active dose of medication during both their morning and evening treatments from the ACCUHALER/DISKUS and a dummy placebo dose in the morning from their NDPI.

Interventions: intervention 1: FF/VI 100/25 Inhalation Powder NDPI intervention 2: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS intervention 3: Placebo Inhalation Powder NDPI intervention 4: Placebo Inhalation Powder ACCUHALER/DISKUS intervention 5: Salbutamol as needed
Intervention descriptions: intervention 1: Subjects randomized to the FF/VI Inhalation Powder Novel Dry Powder Inhaler (NDPI) arm will receive a single inhalation of 100 mcg FF and 25 mcg VI via NDPI every morning for 12 weeks. intervention 2: Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of 250 mcg Fluticasone Propionate and 50 mcg Salmeterol via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks. intervention 3: Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of placebo inhalation powder via NDPI every morning for 12 weeks. intervention 4: Subjects randomized to the FF/VI Inhalation Powder NDPI arm will receive a single inhalation of placebo inhalation powder via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks. intervention 5: Salbutamol inhalation powder

Protocol document: