Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 10/14/2017 |
| Start Date: | November 2, 2005 |
| End Date: | November 7, 2006 |
A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
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.
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.
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).
We found this trial at
73
sites
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