Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Fluticasone propionate/salmeterol combination product; Drug: Salmeterol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984659

112989

Details and patient eligibility

About

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.

Full 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.

Enrollment: 366 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥ 40 years of age
• Established clinical history of COPD by ATS/ERS definition
• Former or current smoker > 10 pack years
• Evidence of dyspnea

Exclusion criteria

• Has a respiratory disorder other than COPD
• Cancer not in complete clinical remission
• Clinically significant cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine, or hematological abnormalities that are uncontrolled

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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366 participants in 3 patient groups, including a placebo group

FSC

Experimental group

Description:

Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day

Treatment:

Drug: Fluticasone propionate/salmeterol combination product

SAL

Experimental group

Description:

Salmeterol 50mcg DISKUS twice a day

Treatment:

Drug: Salmeterol

Placebo

Placebo Comparator group

Description:

Placebo DISKUS twice a day

Treatment:

Drug: Placebo