Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 4:30 AM
Study NCT ID:
NCT00442468
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2007-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'This is a single visit, non-interventional study; hence, AEs were collected during the visit.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting', 'otherNumAtRisk': 1283, 'otherNumAffected': 18, 'seriousNumAtRisk': 1283, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1283, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1283, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'FEV1/FVC<=70%', 'categories': [{'measurements': [{'value': '308', 'groupId': 'OG000'}]}]}, {'title': 'FEV1/FVC>70%', 'categories': [{'measurements': [{'value': '893', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)', 'description': '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).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who completed pre- and post-bronchodilator spirometry'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'None (score=0)', 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}]}]}, {'title': 'Slight (score=1)', 'categories': [{'measurements': [{'value': '572', 'groupId': 'OG000'}]}]}, {'title': 'Moderate (score=2)', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}]}]}, {'title': 'Moderately Severe (score=3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe (score=4)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Very Severe (score=5)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who completed the questionnaire'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Usually have cough', 'categories': [{'measurements': [{'value': '1003', 'groupId': 'OG000'}]}]}, {'title': 'Cough 4-6 times per day for at least 4 days/week', 'categories': [{'measurements': [{'value': '917', 'groupId': 'OG000'}]}]}, {'title': 'Cough when getting up first thing in the morning', 'categories': [{'measurements': [{'value': '927', 'groupId': 'OG000'}]}]}, {'title': 'Coughed during the rest of the day or night', 'categories': [{'measurements': [{'value': '967', 'groupId': 'OG000'}]}]}, {'title': 'Coughed most days for 3 consecutive months', 'categories': [{'measurements': [{'value': '925', 'groupId': 'OG000'}]}]}, {'title': 'Usually produced phlegm', 'categories': [{'measurements': [{'value': '935', 'groupId': 'OG000'}]}]}, {'title': 'Bring up phlegm twice/day for at least 4 days/week', 'categories': [{'measurements': [{'value': '711', 'groupId': 'OG000'}]}]}, {'title': 'Bring up phlegm first thing in the morning', 'categories': [{'measurements': [{'value': '839', 'groupId': 'OG000'}]}]}, {'title': 'Bring up phlegm during rest of the day or night', 'categories': [{'measurements': [{'value': '718', 'groupId': 'OG000'}]}]}, {'title': 'Bring up phlegm most days for 3 months', 'categories': [{'measurements': [{'value': '764', 'groupId': 'OG000'}]}]}, {'title': 'Had cough/phlegm episode for 3 or more weeks/year', 'categories': [{'measurements': [{'value': '641', 'groupId': 'OG000'}]}]}, {'title': 'Wheezy/whistling sound emanating from chest', 'categories': [{'measurements': [{'value': '955', 'groupId': 'OG000'}]}]}, {'title': 'Chest wheezing within week prior to study visit', 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}]}]}, {'title': 'Wheezing occuring with shortness of breath', 'categories': [{'measurements': [{'value': '472', 'groupId': 'OG000'}]}]}, {'title': 'Had a chest illness that kept them at home', 'categories': [{'measurements': [{'value': '487', 'groupId': 'OG000'}]}]}, {'title': 'Had a chest illness that produced phlegm', 'categories': [{'measurements': [{'value': '656', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who completed the questionnaire'}, {'type': 'SECONDARY', 'title': "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", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1275', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Very good', 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '675', 'groupId': 'OG000'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Yes, limited a lot', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}]}]}, {'title': 'Yes, limited a little', 'categories': [{'measurements': [{'value': '437', 'groupId': 'OG000'}]}]}, {'title': 'No, not limited at all', 'categories': [{'measurements': [{'value': '669', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Yes, limited a lot', 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}]}]}, {'title': 'Yes, limited a little', 'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000'}]}]}, {'title': 'No, not limited at all', 'categories': [{'measurements': [{'value': '321', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All the time', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1275', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '620', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Not at all', 'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000'}]}]}, {'title': 'A little bit', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}]}]}, {'title': 'Moderately', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}]}]}, {'title': 'Quite a bit', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}]}]}, {'title': 'Extremely', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '595', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1265', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '446', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'All of the time', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Most of the time', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Some of the time', 'categories': [{'measurements': [{'value': '286', 'groupId': 'OG000'}]}]}, {'title': 'A little of the time', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}]}]}, {'title': 'None of the time', 'categories': [{'measurements': [{'value': '553', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the question'}, {'type': 'SECONDARY', 'title': 'FEV1 and FVC, Pre-bronchodilator Spirometry Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'FEV1', 'categories': [{'measurements': [{'value': '2.46', 'spread': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'FVC', 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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).', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed pre-bronchodilator spirometry'}, {'type': 'SECONDARY', 'title': 'FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'FEV1 percent predicted', 'categories': [{'measurements': [{'value': '78.9', 'spread': '17.21', 'groupId': 'OG000'}]}]}, {'title': 'FEV1/FVC percent predicted', 'categories': [{'measurements': [{'value': '72.2', 'spread': '8.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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).', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed pre-bronchodilator spirometry'}, {'type': 'SECONDARY', 'title': 'FEV1 and FVC, Post-bronchodilator Spirometry Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'FEV1', 'categories': [{'measurements': [{'value': '2.53', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'FVC', 'categories': [{'measurements': [{'value': '3.42', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day visit', 'description': '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).', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed post-bronchodilator spirometry'}, {'type': 'SECONDARY', 'title': 'FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'FEV1 percent predicted', 'categories': [{'measurements': [{'value': '81.4', 'spread': '17.06', 'groupId': 'OG000'}]}]}, {'title': 'FEV1/FVC percent predicted', 'categories': [{'measurements': [{'value': '74.0', 'spread': '9.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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).', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed pre- and post-bronchodilator spirometry'}, {'type': 'SECONDARY', 'title': 'Post-bronchodilator Reversibility Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Non-reversible', 'categories': [{'measurements': [{'value': '1088', 'groupId': 'OG000'}]}]}, {'title': 'Reversible', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed pre- and post-bronchodilator spirometry'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Had lung trouble before age 16', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Ever had attack of bronchitis', 'categories': [{'measurements': [{'value': '627', 'groupId': 'OG000'}]}]}, {'title': 'Had an attack of bronchitis confirmed by doctor', 'categories': [{'measurements': [{'value': '572', 'groupId': 'OG000'}]}]}, {'title': 'Ever had sinus trouble', 'categories': [{'measurements': [{'value': '743', 'groupId': 'OG000'}]}]}, {'title': 'Had sinus trouble confirmed by doctor', 'categories': [{'measurements': [{'value': '557', 'groupId': 'OG000'}]}]}, {'title': 'Ever had tuberculosis', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Had tuberculosis confirmed by doctor', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Ever had pneumonia', 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}]}]}, {'title': 'Had pneumonia confirmed by doctor', 'categories': [{'measurements': [{'value': '407', 'groupId': 'OG000'}]}]}, {'title': 'Ever had fever', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}]}]}, {'title': 'Had fever confirmed by doctor', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}, {'title': 'Ever had asthma', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Still have asthma', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Had asthma confirmed by doctor', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Ever hospitalized overnight for asthma', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Hospitalized overnight for asthma in the last year', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Ever had any other chest illness', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Ever had any chest operation', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Ever had any chest injury', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Hospitalized for lung problems in past 12 months', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Ever been treated with antibiotics for chest', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the questions'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Ever worked fulltime for more than 6 months', 'categories': [{'measurements': [{'value': '1204', 'groupId': 'OG000'}]}]}, {'title': 'Ever worked more than 1 year in any dusty job', 'categories': [{'measurements': [{'value': '1246', 'groupId': 'OG000'}]}]}, {'title': 'Ever been exposed to gas or chemical fumes', 'categories': [{'measurements': [{'value': '433', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the questions'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Completed the Highest Indicated Education Level or Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'No or incomplete primary school', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Completed primary school', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Some high school', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}]}]}, {'title': 'Completed high school', 'categories': [{'measurements': [{'value': '468', 'groupId': 'OG000'}]}]}, {'title': 'Technical post-secondary/further education', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}]}]}, {'title': 'University graduate', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'University post-graduate degree', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the questions'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Experience With Tobacco Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Ever smoked cigarettes', 'categories': [{'measurements': [{'value': '1273', 'groupId': 'OG000'}]}]}, {'title': 'Smoked cigarettes a month before study', 'categories': [{'measurements': [{'value': '1092', 'groupId': 'OG000'}]}]}, {'title': 'Smoked cigarettes in previous 24 hours', 'categories': [{'measurements': [{'value': '1072', 'groupId': 'OG000'}]}]}, {'title': 'Mother was a cigarette smoker', 'categories': [{'measurements': [{'value': '761', 'groupId': 'OG000'}]}]}, {'title': 'Father was a cigarette smoker', 'categories': [{'measurements': [{'value': '949', 'groupId': 'OG000'}]}]}, {'title': 'Smoked pipe regularly', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Exposed to tobacco smoke from others', 'categories': [{'measurements': [{'value': '788', 'groupId': 'OG000'}]}]}, {'title': 'Anyone else smokes regularly at home', 'categories': [{'measurements': [{'value': '583', 'groupId': 'OG000'}]}]}, {'title': 'Anyone else smoked in childhood home', 'categories': [{'measurements': [{'value': '1002', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the questions'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'classes': [{'title': 'Ever been told by a doctor you had heart trouble', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}]}]}, {'title': 'Had treatment for heart trouble in past 10 years', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by doctor you had hypertension', 'categories': [{'measurements': [{'value': '518', 'groupId': 'OG000'}]}]}, {'title': 'Had treatment for hypertension in past 10 years', 'categories': [{'measurements': [{'value': '434', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had angina', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had a heart attack', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had a stroke', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had heart failure', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Even been told by a doctor you had arrhythmia', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had osteoporosis', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had osteoarthritis', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had rheum arthritis', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had IBD', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had diabetes', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had Type I diabetes', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by doctor you had Type II diabetes', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had peptic ulcer', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Ever been told by a doctor you had GERD', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Ever had depression requiring treatment', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}]}]}, {'title': 'Ever had anxiety/panic attacks', 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'description': 'IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant respondents to the questions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1283'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'Did not complete all study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants, With Self-reported Symptoms of Bronchitis', 'description': 'Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '9.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '704', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '579', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White - White/Caucasian/European', 'categories': [{'measurements': [{'value': '1030', 'groupId': 'BG000'}]}]}, {'title': 'African American/African', 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian - Japanese', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Asian - Central/South Central Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawain/Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Current smokers', 'categories': [{'measurements': [{'value': '1116', 'groupId': 'BG000'}]}]}, {'title': 'Former smokers', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of current and former smokers enrolled in the study', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '6.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index (BMI, this is the ratio of the body mass in kilograms \\[kg\\] by the square of the height in meters \\[m2\\])', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2007-03-01', 'resultsFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2007-03-01', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-03', 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%', 'timeFrame': 'Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': 'Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).'}, {'measure': "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", 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': 'FEV1 and FVC, Pre-bronchodilator Spirometry Measures', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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).'}, {'measure': 'FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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).'}, {'measure': 'FEV1 and FVC, Post-bronchodilator Spirometry Measures', 'timeFrame': 'Day 1 of a 1-day visit', 'description': '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).'}, {'measure': 'FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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).'}, {'measure': 'Post-bronchodilator Reversibility Measures', 'timeFrame': 'Day 1 of a 1-day study', 'description': '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.'}, {'measure': 'Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness', 'timeFrame': 'Day 1 of a 1-day study'}, {'measure': 'Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status', 'timeFrame': 'Day 1 of a 1-day study'}, {'measure': 'Number of Participants Who Completed the Highest Indicated Education Level or Grade', 'timeFrame': 'Day 1 of 1-day study'}, {'measure': 'Number of Participants With the Indicated Experience With Tobacco Smoking', 'timeFrame': 'Day 1 of 1-day study'}, {'measure': 'Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History', 'timeFrame': 'Day 1 of 1-day study', 'description': 'IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.'}]}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Chronic Bronchitis', 'Spirometry'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '19757984', 'type': 'BACKGROUND', 'citation': 'Yawn B, Mannino D, Littlejohn T, Ruoff G, Emmett A, Raphiou I, Crater G. Prevalence of COPD among symptomatic patients in a primary care setting. Curr Med Res Opin. 2009 Nov;25(11):2671-7. doi: 10.1185/03007990903241350.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female, ≥40 years of age, current or previous cigarette smokers with ≥10 pack-years of smoking history and self reported symptoms of chronic bronchitis where chronic bronchitis.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 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.\n\nExclusion Criteria:\n\n\\- 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."}, 'identificationModule': {'nctId': 'NCT00442468', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Evaluation of the Prevalence of Airway Obstruction Consistent With Chronic Obstructive Pulmonary Disease (COPD) in Subjects With a History of Cigarette Smoking and Symptoms of Chronic Bronchitis in a Primary Care Setting', 'orgStudyIdInfo': {'id': 'ADC109043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'This is a cross-sectional, non-interventional study. All enrolled subjects were asked to complete a questionnaire and pulmonary function test to assess the prevalence of airflow obstruction.', 'interventionNames': ['Other: Non-interventional study.']}], 'interventions': [{'name': 'Non-interventional study.', 'type': 'OTHER', 'description': 'This is a non-interventional (no drug treatment administered), prevalence (observational) study.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80130', 'city': 'Highlands Ranch', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.55388, 'lon': -104.96943}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '62033', 'city': 'Gillespie', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12977, 'lon': -89.81954}}, {'zip': '60061', 'city': 'Vernon Hills', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.21947, 'lon': -87.97952}}, {'zip': '46515', 'city': 'Elkhart', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.68199, 'lon': -85.97667}}, {'zip': '47711', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '67005', 'city': 'Arkansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.06197, 'lon': -97.03837}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70584', 'city': 'Sunset', 'state': 'Louisiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.41131, 'lon': -92.06845}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55904', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '65714', 'city': 'Nixa', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.04339, 'lon': -93.29435}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28117', 'city': 'Mooresville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.58486, 'lon': -80.81007}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '28779', 'city': 'Sylva', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.37371, 'lon': -83.22598}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '45224', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45406', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45439', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '73099', 'city': 'Yukon', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.50672, 'lon': -97.76254}}, {'zip': '15205', 'city': 'Clairton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.29229, 'lon': -79.88171}}, {'zip': '19438', 'city': 'Harleysville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.27955, 'lon': -75.38712}}, {'zip': '02864', 'city': 'Cumberland', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.96677, 'lon': -71.43284}}, {'zip': '29340', 'city': 'Gaffney', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.07179, 'lon': -81.64982}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29309', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37087', 'city': 'Harleysville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site'}, {'zip': '38358', 'city': 'Milan', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.91979, 'lon': -88.75895}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '98335', 'city': 'Gig Harbor', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.32926, 'lon': -122.58013}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}