Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive Dyspnea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 366
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.

Detailed description:
Dyspnea, referred to by patients as "shortness of breath" or "breathlessness," is frequently associated with decreases in functional status, quality of life, and disabilities. Currently available questionnaires do not specifically address the shortness of breath component of COPD. The development of a patient reported outcome questionnaire that will specifically assess Shortness of Breath with Daily Activities (SOBDA) in patients with COPD is needed.

Arms:
arm 1: Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day arm 2: Salmeterol 50mcg DISKUS twice a day arm 3: Placebo DISKUS twice a day

Interventions: intervention 1: Fluticasone propionate/salmeterol combination product intervention 2: Salmeterol intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day for 8 weeks intervention 2: Salmeterol 50mcg DISKUS twice a day for 8 weeks intervention 3: Placebo DISKUS twice a day for 8 weeks

Protocol document: