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N/A N=1,283

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

Pulmonary Disease, Chronic Obstructive

Enrolled (actual)
1,283
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% — 308; 893 participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Non-interventional study. (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Sep 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%
308; 893
SECONDARY
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale
319; 572; 254; 0; 68; 3
SECONDARY
Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire
1003; 917; 927; 967; 925; 935
SECONDARY
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
45; 281; 675; 236; 38
SECONDARY
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
166; 437; 669
SECONDARY
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
336; 612; 321
SECONDARY
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
69; 178; 345; 311; 373
SECONDARY
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
91; 144; 334; 264; 439
SECONDARY
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
36; 129; 287; 306; 517
SECONDARY
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
22; 89; 249; 293; 620
SECONDARY
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
387; 258; 249; 207; 73
SECONDARY
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
84; 595; 372; 172; 50
SECONDARY
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
58; 367; 446; 300; 94
SECONDARY
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
32; 111; 365; 400; 357
SECONDARY
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
40; 107; 286; 282; 553
SECONDARY
FEV1 and FVC, Pre-bronchodilator Spirometry Measures
2.46; 3.46
SECONDARY
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures
78.9; 72.2
SECONDARY
FEV1 and FVC, Post-bronchodilator Spirometry Measures
2.53; 3.42
SECONDARY
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures
81.4; 74.0
SECONDARY
Post-bronchodilator Reversibility Measures
1088; 113
SECONDARY
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness
62; 627; 572; 743; 557; 11
SECONDARY
Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status
1204; 1246; 433
SECONDARY
Number of Participants Who Completed the Highest Indicated Education Level or Grade
5; 28; 163; 468; 358; 154
SECONDARY
Number of Participants With the Indicated Experience With Tobacco Smoking
1273; 1092; 1072; 761; 949; 66
SECONDARY
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History
163; 122; 518; 434; 79; 58

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00442468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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