Clinical trial NCT00442468: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Chronic Bronchitis
Spirometry
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 1283
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female, ≥40 years of age, current or previous cigarette smokers with ≥10 pack-years of smoking history and self reported symptoms of chronic bronchitis where chronic bronchitis.

Brief summary: 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).


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

Primary outcomes:
measure: Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%
timeFrame: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)
Secondary outcomes:
measure: Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire
timeFrame: Day 1 of 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey
timeFrame: Day 1 of a 1-day study
measure: FEV1 and FVC, Pre-bronchodilator Spirometry Measures
timeFrame: Day 1 of a 1-day study
measure: FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures
timeFrame: Day 1 of a 1-day study
measure: FEV1 and FVC, Post-bronchodilator Spirometry Measures
timeFrame: Day 1 of a 1-day visit
measure: FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures
timeFrame: Day 1 of a 1-day study
measure: Post-bronchodilator Reversibility Measures
timeFrame: Day 1 of a 1-day study
measure: Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness
timeFrame: Day 1 of a 1-day study
measure: Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status
timeFrame: Day 1 of a 1-day study
measure: Number of Participants Who Completed the Highest Indicated Education Level or Grade
timeFrame: Day 1 of 1-day study
measure: Number of Participants With the Indicated Experience With Tobacco Smoking
timeFrame: Day 1 of 1-day study
measure: Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History
timeFrame: Day 1 of 1-day study
Other outcomes:
Locations:
city: Highlands Ranch
country: United States
facility: GSK Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Largo
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Gillespie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Vernon Hills
country: United States
facility: GSK Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Arkansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Nixa
country: United States
facility: GSK Investigational Site
state: Missouri
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Fremont
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Mooresville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Sylva
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Kettering
country: United States
facility: GSK Investigational Site
state: Ohio
city: Yukon
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Clairton
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Harleysville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Cumberland
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Gaffney
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Union
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Harleysville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Milan
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Gig Harbor
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.