Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: DISKUS Salmeterol Fluticasone Propionate Chronic Obstructive Pulmonary Disease (COPD) Hydroflouroalkane COPD HFA MDI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg intervention 2: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg
Intervention descriptions: intervention 1: treatment drug intervention 2: treatment drug

Protocol document: