Last updated: 11/04/2018 04:31:28
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: 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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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)
Secondary outcomes:
Number of participants with the indicated scores on the MRC (Medical Research Council) dyspnea scale
Timeframe: Day 1 of a 1-day study
Number of participants with an affirmative response to specific categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire
Timeframe: Day 1 of 1-day study
Number of participants with the indicated responses to the question of how they'd rate their general health, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of whether their health is limited in moderate activities, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of whether their health is limited in climbing stairs, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of whether they had accomplished less than they would like, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they were limited in the kind of work/activities, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they accomplished less due to emotional problems, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they did work less carefully due to emotional problems, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of to what degree does pain interfere with normal work, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they felt calm and peaceful, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they have a lot of energy, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they felt downhearted and depressed, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
Number of participants with the indicated responses to the question of how often they experience interference with social activities, a question on the 12-item short form health survey
Timeframe: Day 1 of a 1-day study
FEV1 and FVC, Pre-bronchodilator Spirometry Measures
Timeframe: Day 1 of a 1-day study
FEV1 percent predicted and FEV1/FVC percent predicted, Pre-bronchodilator Spirometry Measures
Timeframe: Day 1 of a 1-day study
FEV1 and FVC, Post-bronchodilator Spirometry Measures
Timeframe: Day 1 of a 1-day visit
FEV1 percent predicted and FEV1/FVC percent predicted, Post-bronchodilator Spirometry Measures
Timeframe: Day 1 of a 1-day study
Post-bronchodilator Reversibility Measures
Timeframe: Day 1 of a 1-day study
Number of participants who responded "yes" to respective questions regarding past illness
Timeframe: Day 1 of a 1-day study
Number of participants who responded "yes" to respective questions regarding occupational history and socioeconomic status
Timeframe: Day 1 of a 1-day study
Number of participants who completed the highest indicated education level or grade
Timeframe: Day 1 of 1-day study
Number of participants with the indicated experience with tobacco smoking
Timeframe: Day 1 of 1-day study
Number of participants who responded "yes" when asked indicated questions regarding medical history
Timeframe: Day 1 of 1-day study
Interventions:
Other: Non-interventional study.
Enrollment:
1283
Observational study model:
Other
Primary completion date:
2007-28-09
Time perspective:
Prospective
Clinical publications:
Prevalence of COPD among symptomatic patients in a primary care setting. Yawn B, Mannino D, Littlejohn T, Ruoff G, Emmett A, Raphiou I, Crater G. Curr Med Res Opin. 2009 Nov;25(11):2671-7.
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.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2007 to September 2007
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female
- ≥40 years of age
- Current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack/years
- Self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years
- Completion of written informed consent prior to study participation
- Subject must be able to read, comprehend, and record information in English.
Exclusion criteria:
- Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists.
- Previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc.
- Current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency.
- Any medical or physical condition that would interfere with the adequate performance of spirometry.
- Evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit.
- A spirometrically confirmed diagnosis of COPD.
- Have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse.
- Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject’s participation in the study.
- Pregnant females.
- Participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs.
Trial location(s)
Location
GSK Investigational Site
Gig Harbor, Washington, United States, 98335
Status
Study Complete
Location
GSK Investigational Site
Harleysville, Tennessee, United States, 37087
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Harleysville, Pennsylvania, United States, 19438
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29309
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Missoula, Montana, United States, 59808
Status
Study Complete
Location
GSK Investigational Site
Gillespie, Illinois, United States, 62033
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
Status
Study Complete
Location
GSK Investigational Site
Mooresville, North Carolina, United States, 28117
Status
Study Complete
Location
GSK Investigational Site
Vernon Hills, Illinois, United States, 60061
Status
Study Complete
Location
GSK Investigational Site
Sylva, North Carolina, United States, 28779
Status
Study Complete
Location
GSK Investigational Site
Highlands Ranch, Colorado, United States, 80130
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Milan, Tennessee, United States, 38358
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Rhode Island, United States, 02864
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55414
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46515
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47711
Status
Study Complete
Location
GSK Investigational Site
Arkansas City, Kansas, United States, 67005
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Fremont, Nebraska, United States, 68025
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55904
Status
Study Complete
Location
GSK Investigational Site
Clairton, Pennsylvania, United States, 15205
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2007-28-09
Actual study completion date
2007-28-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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