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

Completed

Conditions studied: Pulmonary Disease, Chronic Obstructive, Infections, Bacterial

In brief

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.

Key facts

Study ID

NCT00259909

Run by

GlaxoSmithKline

People needed

259

Starts

2005-11-02

Expected to finish

2006-11-07

Last updated by the study team

2017-10-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Hueytown, Alabama, United States
• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Fort Collins, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Hartford, Connecticut, United States
• GSK Investigational Site — Hartford, Connecticut, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Pensacola, Florida, United States
• GSK Investigational Site — Pensacola, Florida, United States
• GSK Investigational Site — Sarasota, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Austell, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Hines, Illinois, United States
• GSK Investigational Site — North Chicago, Illinois, United States
• GSK Investigational Site — Peoria, Illinois, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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