Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis, Spirometry
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).
Interventions
This is a non-interventional (no drug treatment administered), prevalence (observational) study.
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% | Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Day 1 of 1-day study | The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm). |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| FEV1 and FVC, Post-bronchodilator Spirometry Measures | Day 1 of a 1-day visit | 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). |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of a 1-day study | 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. |
| FEV1 and FVC, Pre-bronchodilator Spirometry Measures | Day 1 of a 1-day study | 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). |
| FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures | Day 1 of a 1-day study | 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). |
| FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures | Day 1 of a 1-day study | 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). |
| Post-bronchodilator Reversibility Measures | Day 1 of a 1-day study | 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. |
| 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 | Day 1 of 1-day study | IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease. |
| 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 | Day 1 of a 1-day study | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,283 |
| Total | 1,283 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Did not complete all study procedures | 88 |
| Overall Study | Withdrawal by Subject | 91 |
Baseline characteristics
| Characteristic | All Participants, With Self-reported Symptoms of Bronchitis |
|---|---|
| Age Continuous | 52.9 years STANDARD_DEVIATION 9.08 |
| BMI | 28.7 kg/m2 STANDARD_DEVIATION 6.52 |
| Race/Ethnicity, Customized African American/African | 219 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 13 participants |
| Race/Ethnicity, Customized Asian - Central/South Central Asian Heritage | 1 participants |
| Race/Ethnicity, Customized Asian - Japanese | 2 participants |
| Race/Ethnicity, Customized Mixed Race | 3 participants |
| Race/Ethnicity, Customized Native Hawain/Pacific Islander | 1 participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 14 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 1030 participants |
| Sex: Female, Male Female | 704 Participants |
| Sex: Female, Male Male | 579 Participants |
| Smoking Status Current smokers | 1116 participants |
| Smoking Status Former smokers | 167 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 1,283 |
| serious Total, serious adverse events | 0 / 1,283 |
Outcome results
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).
Time frame: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)
Population: All enrolled participants who completed pre- and post-bronchodilator spirometry
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% | FEV1/FVC<=70% | 308 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% | FEV1/FVC>70% | 893 participants |
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).
Time frame: Day 1 of a 1-day visit
Population: All participants who completed post-bronchodilator spirometry
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 and FVC, Post-bronchodilator Spirometry Measures | FEV1 | 2.53 Liters | Standard Deviation 0.73 |
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 and FVC, Post-bronchodilator Spirometry Measures | FVC | 3.42 Liters | Standard Deviation 0.91 |
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).
Time frame: Day 1 of a 1-day study
Population: All participants who completed pre-bronchodilator spirometry
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 and FVC, Pre-bronchodilator Spirometry Measures | FEV1 | 2.46 Liters (L) | Standard Deviation 0.72 |
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 and FVC, Pre-bronchodilator Spirometry Measures | FVC | 3.46 Liters (L) | Standard Deviation 0.92 |
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).
Time frame: Day 1 of a 1-day study
Population: All participants who completed pre- and post-bronchodilator spirometry
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures | FEV1 percent predicted | 81.4 percentage | Standard Deviation 17.06 |
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures | FEV1/FVC percent predicted | 74.0 percentage | Standard Deviation 9.13 |
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).
Time frame: Day 1 of a 1-day study
Population: All participants who completed pre-bronchodilator spirometry
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures | FEV1 percent predicted | 78.9 percentage | Standard Deviation 17.21 |
| All Participants, With Self-reported Symptoms of Bronchitis | FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures | FEV1/FVC percent predicted | 72.2 percentage | Standard Deviation 8.77 |
Secondary
Number of Participants Who Completed the Highest Indicated Education Level or Grade
Time frame: Day 1 of 1-day study
Population: All participant respondents to the questions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | No or incomplete primary school | 5 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | Completed primary school | 28 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | Some high school | 163 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | Completed high school | 468 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | Technical post-secondary/further education | 358 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | University graduate | 154 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Completed the Highest Indicated Education Level or Grade | University post-graduate degree | 39 participants |
Secondary
Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the questions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status | Ever worked fulltime for more than 6 months | 1204 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status | Ever worked more than 1 year in any dusty job | 1246 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status | Ever been exposed to gas or chemical fumes | 433 participants |
Secondary
Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the questions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had lung trouble before age 16 | 62 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had attack of bronchitis | 627 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had an attack of bronchitis confirmed by doctor | 572 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had sinus trouble | 743 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had sinus trouble confirmed by doctor | 557 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had tuberculosis | 11 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had tuberculosis confirmed by doctor | 13 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had pneumonia | 436 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had pneumonia confirmed by doctor | 407 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had fever | 274 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had fever confirmed by doctor | 168 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had asthma | 98 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Still have asthma | 40 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Had asthma confirmed by doctor | 88 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever hospitalized overnight for asthma | 15 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Hospitalized overnight for asthma in the last year | 4 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had any other chest illness | 99 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had any chest operation | 30 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever had any chest injury | 76 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Hospitalized for lung problems in past 12 months | 12 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness | Ever been treated with antibiotics for chest | 235 participants |
Secondary
Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History
IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.
Time frame: Day 1 of 1-day study
Population: All participant respondents to the questions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had heart trouble | 163 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Had treatment for heart trouble in past 10 years | 122 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by doctor you had hypertension | 518 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Had treatment for hypertension in past 10 years | 434 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had angina | 79 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had a heart attack | 58 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had a stroke | 31 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had heart failure | 17 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Even been told by a doctor you had arrhythmia | 56 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had osteoporosis | 96 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had osteoarthritis | 190 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had rheum arthritis | 119 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had IBD | 76 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had diabetes | 154 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had Type I diabetes | 19 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by doctor you had Type II diabetes | 124 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had peptic ulcer | 70 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever been told by a doctor you had GERD | 45 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever had depression requiring treatment | 365 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History | Ever had anxiety/panic attacks | 325 participants |
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).
Time frame: Day 1 of 1-day study
Population: All study participants who completed the questionnaire
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Coughed during the rest of the day or night | 967 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Usually have cough | 1003 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Cough 4-6 times per day for at least 4 days/week | 917 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Cough when getting up first thing in the morning | 927 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Coughed most days for 3 consecutive months | 925 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Usually produced phlegm | 935 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Bring up phlegm twice/day for at least 4 days/week | 711 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Bring up phlegm first thing in the morning | 839 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Bring up phlegm during rest of the day or night | 718 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Bring up phlegm most days for 3 months | 764 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Had cough/phlegm episode for 3 or more weeks/year | 641 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Wheezy/whistling sound emanating from chest | 955 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Chest wheezing within week prior to study visit | 332 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Wheezing occuring with shortness of breath | 472 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Had a chest illness that kept them at home | 487 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire | Had a chest illness that produced phlegm | 656 participants |
Secondary
Number of Participants With the Indicated Experience With Tobacco Smoking
Time frame: Day 1 of 1-day study
Population: All participant respondents to the questions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Ever smoked cigarettes | 1273 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Smoked cigarettes a month before study | 1092 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Smoked cigarettes in previous 24 hours | 1072 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Mother was a cigarette smoker | 761 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Father was a cigarette smoker | 949 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Smoked pipe regularly | 66 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Exposed to tobacco smoke from others | 788 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Anyone else smokes regularly at home | 583 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Experience With Tobacco Smoking | Anyone else smoked in childhood home | 1002 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 36 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 129 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 287 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 306 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 517 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 22 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 89 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 249 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 293 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 620 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 40 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 107 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 286 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 282 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 553 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 84 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 595 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 372 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 172 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 50 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 32 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 111 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 365 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 400 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 357 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 58 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 367 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 446 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 300 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 94 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All of the time | 91 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 144 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 334 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 264 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 439 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Excellent | 45 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Very good | 281 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Good | 675 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Fair | 236 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Poor | 38 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Not at all | 387 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little bit | 258 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Moderately | 249 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Quite a bit | 207 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Extremely | 73 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Yes, limited a lot | 336 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Yes, limited a little | 612 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | No, not limited at all | 321 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Yes, limited a lot | 166 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Yes, limited a little | 437 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | No, not limited at all | 669 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participant respondents to the question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | All the time | 69 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Most of the time | 178 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | Some of the time | 345 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | A little of the time | 311 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | 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 | None of the time | 373 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All enrolled participants who completed the questionnaire
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | None (score=0) | 319 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | Slight (score=1) | 572 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | Moderate (score=2) | 254 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | Moderately Severe (score=3) | 0 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | Severe (score=4) | 68 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale | Very Severe (score=5) | 3 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participants who completed pre- and post-bronchodilator spirometry
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants, With Self-reported Symptoms of Bronchitis | Post-bronchodilator Reversibility Measures | Non-reversible | 1088 participants |
| All Participants, With Self-reported Symptoms of Bronchitis | Post-bronchodilator Reversibility Measures | Reversible | 113 participants |