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
Bottom Line
View on ClinicalTrials.gov: NCT00442468 ↗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
| Outcome | Result | p-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.
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.