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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

NCT ID: NCT00442468

Last Updated: 2013-01-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

This is a cross-sectional, non-interventional study. All enrolled subjects were asked to complete a questionnaire and pulmonary function test to assess the prevalence of airflow obstruction.

Non-interventional study.

Intervention Type OTHER

This is a non-interventional (no drug treatment administered), prevalence (observational) study.

Interventions

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Non-interventional study.

This is a non-interventional (no drug treatment administered), prevalence (observational) study.

Intervention Type OTHER

Eligibility Criteria

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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. - Participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Highlands Ranch, Colorado, United States

Site Status

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Gillespie, Illinois, United States

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Vernon Hills, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Arkansas City, Kansas, United States

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Wichita, Kansas, United States

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Sunset, Louisiana, United States

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Kalamazoo, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Nixa, Missouri, United States

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Missoula, Montana, United States

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Fremont, Nebraska, United States

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Charlotte, North Carolina, United States

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Mooresville, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Sylva, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Yukon, Oklahoma, United States

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Clairton, Pennsylvania, United States

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Harleysville, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Bristol, Tennessee, United States

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Harleysville, Tennessee, United States

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Milan, Tennessee, United States

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Plano, Texas, United States

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Newport News, Virginia, United States

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GSK Investigational Site

Gig Harbor, Washington, United States

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GSK Investigational Site

Tacoma, Washington, United States

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Countries

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United States

References

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Yawn B, Mannino D, Littlejohn T, Ruoff G, Emmett A, Raphiou I, Crater G. Prevalence of COPD among symptomatic patients in a primary care setting. Curr Med Res Opin. 2009 Nov;25(11):2671-7. doi: 10.1185/03007990903241350.

Reference Type BACKGROUND
PMID: 19757984 (View on PubMed)

Other Identifiers

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ADC109043

Identifier Type: -

Identifier Source: org_study_id

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