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

Completed

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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).

Key facts

Study ID

NCT00442468

Run by

GlaxoSmithKline

People needed

1283

Starts

2007-04-01

Expected to finish

2007-09-01

Last updated by the study team

2013-01-10

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Highlands Ranch, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Largo, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Gillespie, Illinois, United States
• GSK Investigational Site — Vernon Hills, Illinois, United States
• GSK Investigational Site — Elkhart, Indiana, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Arkansas City, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Rochester, Minnesota, United States
• GSK Investigational Site — Nixa, Missouri, United States
• GSK Investigational Site — Missoula, Montana, United States
• GSK Investigational Site — Fremont, Nebraska, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Mooresville, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Salisbury, North Carolina, United States
• GSK Investigational Site — Sylva, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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