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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00259909
First received: November 29, 2005
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  Purpose

The primary objective of the study is to validate the questionnaire in patients who have sudden, sustained worsening of their baseline condition commonly known as chronic obstructive pulmonary disease (COPD).


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Observational Study for the Psychometric Validation of a Patient-Reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 740
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259909

  Show 103 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00259909     History of Changes
Other Study ID Numbers: OPL104226
Study First Received: November 29, 2005
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Patient reported outcomes
acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013