Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Bacterial; Pulmonary Disease, Chronic Obstructive

Treatments: Other: Global Efficacy questionnaire; Other: GSK questionnaire; Other: Acute Short Form 12 version 2; Other: St. George's Respiratory Questionnaire

Study type: Observational

Funder types: Industry

Identifiers

NCT00259909

OPL104226

Details and patient eligibility

About

The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient's perspective. At a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who experience acute exacerbations of their COPD.

Enrollment: 259 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 15 pack-year smoking history.
• Confirmed diagnosis of COPD.
• Have two documented episodes of acute exacerbation in past 12 months.

Exclusion criteria

• Clinical diagnosis of asthma.
• Subjects not literate in the language of the questionnaire (e.g. US English).

Trial design

259 participants in 1 patient group

Subjects with COPD

Description:

Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.

Treatment:

Other: Global Efficacy questionnaire

Other: GSK questionnaire

Other: Acute Short Form 12 version 2

Other: St. George's Respiratory Questionnaire