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

Study Overview
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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).

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Non-interventional study.


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>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. | Other: Non-interventional study.<br>* This is a non-interventional (no drug treatment administered), prevalence (observational) study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% | Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD). | Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing. | Day 1 of a 1-day study | 
| Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm). | Day 1 of 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| 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 | The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health. | Day 1 of a 1-day study | 
| FEV1 and FVC, Pre-bronchodilator Spirometry Measures | Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration). | Day 1 of a 1-day study | 
| FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures | Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). | Day 1 of a 1-day study | 
| FEV1 and FVC, Post-bronchodilator Spirometry Measures | Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration). | Day 1 of a 1-day visit | 
| FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures | Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). | Day 1 of a 1-day study | 
| Post-bronchodilator Reversibility Measures | To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases. | Day 1 of a 1-day study | 
| Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness |  | Day 1 of a 1-day study | 
| Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status |  | Day 1 of a 1-day study | 
| Number of Participants Who Completed the Highest Indicated Education Level or Grade |  | Day 1 of 1-day study | 
| Number of Participants With the Indicated Experience With Tobacco Smoking |  | Day 1 of 1-day study | 
| Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease. | Day 1 of 1-day study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis, Spirometry