| Primary | 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). | All enrolled participants who completed pre- and post-bronchodilator spirometry | Posted | | Number | | participants | | Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff) | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| | | Title | Denominators | Categories |
|---|
| FEV1/FVC<=70% | | | | FEV1/FVC>70% | | |
| |
| Secondary | 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. | All enrolled participants who completed the questionnaire | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | 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). | All study participants who completed the questionnaire | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| 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 | 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. | All participant respondents to the question | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | 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). | All participants who completed pre-bronchodilator spirometry | Posted | | Mean | Standard Deviation | Liters (L) | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | 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). | All participants who completed pre-bronchodilator spirometry | Posted | | Mean | Standard Deviation | percentage | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | 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). | All participants who completed post-bronchodilator spirometry | Posted | | Mean | Standard Deviation | Liters | | Day 1 of a 1-day visit | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | 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). | All participants who completed pre- and post-bronchodilator spirometry | Posted | | Mean | Standard Deviation | percentage | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | 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. | All participants who completed pre- and post-bronchodilator spirometry | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |
| Secondary | Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness | | All participant respondents to the questions | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| | |
| Secondary | Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status | | All participant respondents to the questions | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| | |
| Secondary | Number of Participants Who Completed the Highest Indicated Education Level or Grade | | All participant respondents to the questions | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| | |
| Secondary | Number of Participants With the Indicated Experience With Tobacco Smoking | | All participant respondents to the questions | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| | |
| Secondary | Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History | IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease. | All participant respondents to the questions | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
|---|
| OG000 | All Participants, With Self-reported Symptoms of Bronchitis | Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting |
| |