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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00442468
Recruitment Status : Completed
First Posted : March 2, 2007
Results First Posted : January 7, 2010
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The study does not involve testing of a drug (no treatment intervention). The study will will use spirometry (breathing tests) in subjects of 40 years of age and older with a history of cigarette smoking with chronic bronchitis to check their disease status and whether or not they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a list of questions on paper).

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Non-interventional study.

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Study Type : Observational
Actual Enrollment : 1283 participants
Time Perspective: Prospective
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
Study Start Date : April 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All participants
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.
Other: Non-interventional study.
This is a non-interventional (no drug treatment administered), prevalence (observational) study.




Primary Outcome Measures :
  1. Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70% [ Time Frame: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff) ]
    Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).


Secondary Outcome Measures :
  1. Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale [ Time Frame: Day 1 of a 1-day study ]
    The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.

  2. Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire [ Time Frame: Day 1 of 1-day study ]
    The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).

  3. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  4. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  5. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  6. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  7. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  8. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  9. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  10. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  11. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  12. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  13. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  14. 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 [ Time Frame: Day 1 of a 1-day study ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  15. FEV1 and FVC, Pre-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day study ]
    Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).

  16. FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day study ]
    Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).

  17. FEV1 and FVC, Post-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day visit ]
    Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).

  18. FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day study ]
    Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).

  19. Post-bronchodilator Reversibility Measures [ Time Frame: Day 1 of a 1-day study ]
    To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.

  20. Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness [ Time Frame: Day 1 of a 1-day study ]
  21. Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status [ Time Frame: Day 1 of a 1-day study ]
  22. Number of Participants Who Completed the Highest Indicated Education Level or Grade [ Time Frame: Day 1 of 1-day study ]
  23. Number of Participants With the Indicated Experience With Tobacco Smoking [ Time Frame: Day 1 of 1-day study ]
  24. Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History [ Time Frame: Day 1 of 1-day study ]
    IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442468


Locations
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United States, Colorado
GSK Investigational Site
Highlands Ranch, Colorado, United States, 80130
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33756
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Largo, Florida, United States, 33770
GSK Investigational Site
Miami, Florida, United States, 33156
United States, Illinois
GSK Investigational Site
Gillespie, Illinois, United States, 62033
GSK Investigational Site
Vernon Hills, Illinois, United States, 60061
United States, Indiana
GSK Investigational Site
Elkhart, Indiana, United States, 46515
GSK Investigational Site
Evansville, Indiana, United States, 47711
United States, Kansas
GSK Investigational Site
Arkansas City, Kansas, United States, 67005
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Louisiana
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55414
GSK Investigational Site
Rochester, Minnesota, United States, 55904
United States, Missouri
GSK Investigational Site
Nixa, Missouri, United States, 65714
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59808
United States, Nebraska
GSK Investigational Site
Fremont, Nebraska, United States, 68025
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Mooresville, North Carolina, United States, 28117
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
GSK Investigational Site
Sylva, North Carolina, United States, 28779
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Beachwood, Ohio, United States, 44122
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
GSK Investigational Site
Columbus, Ohio, United States, 43215
GSK Investigational Site
Dayton, Ohio, United States, 45406
GSK Investigational Site
Dayton, Ohio, United States, 45439
GSK Investigational Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
GSK Investigational Site
Yukon, Oklahoma, United States, 73099
United States, Pennsylvania
GSK Investigational Site
Clairton, Pennsylvania, United States, 15205
GSK Investigational Site
Harleysville, Pennsylvania, United States, 19438
United States, Rhode Island
GSK Investigational Site
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Union, South Carolina, United States, 29309
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Harleysville, Tennessee, United States, 37087
GSK Investigational Site
Milan, Tennessee, United States, 38358
United States, Texas
GSK Investigational Site
Plano, Texas, United States, 75093
United States, Virginia
GSK Investigational Site
Newport News, Virginia, United States, 23606
United States, Washington
GSK Investigational Site
Gig Harbor, Washington, United States, 98335
GSK Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00442468    
Other Study ID Numbers: ADC109043
First Posted: March 2, 2007    Key Record Dates
Results First Posted: January 7, 2010
Last Update Posted: January 10, 2013
Last Verified: October 2012
Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Bronchitis
Spirometry
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections