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Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00442468
  Purpose

The study does not involve testing of a drug (no treatment intervention). The study will will use spirometry (breathing tests) in subjects of 40 years of age and older with a history of cigarette smoking with chronic bronchitis to check their disease status and whether or not they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a list of questions on paper).


Condition
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD)

MedlinePlus related topics: Breathing Problems Bronchitis COPD (Chronic Obstructive Pulmonary Disease) Smoking
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: An Evaluation of the Prevalence of Airway Obstruction Consistent With Chronic Obstructive Pulmonary Disease (COPD) in Subjects With a History of Cigarette Smoking and Symptoms of Chronic Bronchitis in a Primary Care Setting

Further study details as provided by GlaxoSmithKline:

Secondary Outcome Measures:
  • Secondary assessments will include evaluations of baseline FEV1, FEV1 reversibility to albuterol, demographics, concomitant medications, occupational status and exposures,
  • education level, medical and smoking history, respiratory symptoms and disorders, work and non-work activities missed due to breathing problems,
  • and health status using the short-form 12 item health survey (SF-12 version 2) and shortness of breath using the modified medical research council dyspnea scale (MMRC). Safety will be assessed by adverse event monitoring.

Estimated Enrollment: 1200
Study Start Date: April 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Male or female, ≥40 years of age, Current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack-years, Self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years, Completion of written informed consent prior to study participation, subject must be able to read, comprehend, and record information in English.

Exclusion Criteria:

  • Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists. Previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc. Current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency. Any medical or physical condition that would interfere with the adequate performance of spirometry. Evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit. A spirometrically confirmed diagnosis of COPD. Have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse. Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject's participation in the study. Pregnant females. Is a participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442468

  Show 47 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: ADC109043
Study First Received: March 1, 2007
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00442468  
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD)
Spirometry

Study placed in the following topic categories:
Acute Disease
Respiration Disorders
Cough
Bronchitis, Chronic
Smoking
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Bronchitis
Airway Obstruction
Dyspnea
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009