Trial Outcomes & Findings for Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath (NCT NCT00442468)

NCT ID: NCT00442468

Last Updated: 2013-01-10

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 1283 participants
• Primary outcome timeframe: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)
• Results posted on: 2013-01-10

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	1283
Overall Study COMPLETED	1100
Overall Study NOT COMPLETED	183

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	91
Overall Study Did not complete all study procedures	88

Baseline Characteristics

Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath

Baseline characteristics by cohort

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Age Continuous	52.9 years STANDARD_DEVIATION 9.08 • n=5 Participants
Sex: Female, Male Female	704 Participants n=5 Participants
Sex: Female, Male Male	579 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European	1030 participants n=5 Participants
Race/Ethnicity, Customized African American/African	219 participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	14 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	13 participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	3 participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese	2 participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Central Asian Heritage	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawain/Pacific Islander	1 participants n=5 Participants
Smoking Status Current smokers	1116 participants n=5 Participants
Smoking Status Former smokers	167 participants n=5 Participants
BMI	28.7 kg/m2 STANDARD_DEVIATION 6.52 • n=5 Participants

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1201 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% FEV1/FVC<=70%	308 participants
Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% FEV1/FVC>70%	893 participants

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All enrolled participants who completed the questionnaire

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1216 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale None (score=0)	319 participants
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale Slight (score=1)	572 participants
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale Moderate (score=2)	254 participants
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale Moderately Severe (score=3)	0 participants
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale Severe (score=4)	68 participants
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale Very Severe (score=5)	3 participants

SECONDARY outcome

Timeframe: Day 1 of 1-day study

Population: All study participants who completed the questionnaire

The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire Usually have cough	1003 participants
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
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
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
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
Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire Usually produced phlegm	935 participants
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
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
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
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
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1275 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1272 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1269 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1276 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1272 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1275 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1273 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1273 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1273 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1265 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1268 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the question

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1268 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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
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
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 outcome

Timeframe: Day 1 of a 1-day study

Population: All participants who completed pre-bronchodilator spirometry

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).

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1273 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
FEV1 and FVC, Pre-bronchodilator Spirometry Measures FEV1	2.46 Liters (L) Standard Deviation 0.72
FEV1 and FVC, Pre-bronchodilator Spirometry Measures FVC	3.46 Liters (L) Standard Deviation 0.92

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants who completed pre-bronchodilator spirometry

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).

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1273 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures FEV1 percent predicted	78.9 percentage Standard Deviation 17.21
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures FEV1/FVC percent predicted	72.2 percentage Standard Deviation 8.77

SECONDARY outcome

Timeframe: Day 1 of a 1-day visit

Population: All participants who completed post-bronchodilator spirometry

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).

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1201 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
FEV1 and FVC, Post-bronchodilator Spirometry Measures FEV1	2.53 Liters Standard Deviation 0.73
FEV1 and FVC, Post-bronchodilator Spirometry Measures FVC	3.42 Liters Standard Deviation 0.91

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants who completed pre- and post-bronchodilator spirometry

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).

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1201 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures FEV1 percent predicted	81.4 percentage Standard Deviation 17.06
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures FEV1/FVC percent predicted	74.0 percentage Standard Deviation 9.13

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants who completed pre- and post-bronchodilator spirometry

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.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1201 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Post-bronchodilator Reversibility Measures Non-reversible	1088 participants
Post-bronchodilator Reversibility Measures Reversible	113 participants

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the questions

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had lung trouble before age 16	62 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had attack of bronchitis	627 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had an attack of bronchitis confirmed by doctor	572 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had sinus trouble	743 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had sinus trouble confirmed by doctor	557 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had tuberculosis	11 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had tuberculosis confirmed by doctor	13 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had pneumonia	436 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had pneumonia confirmed by doctor	407 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had fever	274 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had fever confirmed by doctor	168 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had asthma	98 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Still have asthma	40 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Had asthma confirmed by doctor	88 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever hospitalized overnight for asthma	15 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Hospitalized overnight for asthma in the last year	4 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had any other chest illness	99 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had any chest operation	30 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever had any chest injury	76 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Hospitalized for lung problems in past 12 months	12 participants
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness Ever been treated with antibiotics for chest	235 participants

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participant respondents to the questions

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
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
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 outcome

Timeframe: Day 1 of 1-day study

Population: All participant respondents to the questions

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1215 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Number of Participants Who Completed the Highest Indicated Education Level or Grade No or incomplete primary school	5 participants
Number of Participants Who Completed the Highest Indicated Education Level or Grade Completed primary school	28 participants
Number of Participants Who Completed the Highest Indicated Education Level or Grade Some high school	163 participants
Number of Participants Who Completed the Highest Indicated Education Level or Grade Completed high school	468 participants
Number of Participants Who Completed the Highest Indicated Education Level or Grade Technical post-secondary/further education	358 participants
Number of Participants Who Completed the Highest Indicated Education Level or Grade University graduate	154 participants
Number of Participants Who Completed the Highest Indicated Education Level or Grade University post-graduate degree	39 participants

SECONDARY outcome

Timeframe: Day 1 of 1-day study

Population: All participant respondents to the questions

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Number of Participants With the Indicated Experience With Tobacco Smoking Ever smoked cigarettes	1273 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Smoked cigarettes a month before study	1092 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Smoked cigarettes in previous 24 hours	1072 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Mother was a cigarette smoker	761 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Father was a cigarette smoker	949 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Smoked pipe regularly	66 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Exposed to tobacco smoke from others	788 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Anyone else smokes regularly at home	583 participants
Number of Participants With the Indicated Experience With Tobacco Smoking Anyone else smoked in childhood home	1002 participants

SECONDARY outcome

Timeframe: Day 1 of 1-day study

Population: All participant respondents to the questions

IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.

Outcome measures

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 Participants Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
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
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Had treatment for heart trouble in past 10 years	122 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by doctor you had hypertension	518 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Had treatment for hypertension in past 10 years	434 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by a doctor you had angina	79 participants
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
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
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
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Even been told by a doctor you had arrhythmia	56 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by a doctor you had osteoporosis	96 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by a doctor you had osteoarthritis	190 participants
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
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by a doctor you had IBD	76 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by a doctor you had diabetes	154 participants
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
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
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
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever been told by a doctor you had GERD	45 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever had depression requiring treatment	365 participants
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History Ever had anxiety/panic attacks	325 participants

Adverse Events

All Participants, With Self-reported Symptoms of Bronchitis

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants, With Self-reported Symptoms of Bronchitis n=1283 participants at risk Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
Nervous system disorders Dizziness	1.4% 18/1283 • This is a single visit, non-interventional study; hence, AEs were collected during the visit.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.94% 12/1283 • This is a single visit, non-interventional study; hence, AEs were collected during the visit.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER