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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00442468
First received: March 1, 2007
Last updated: January 4, 2013
Last verified: October 2012
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Other: Non-interventional study.

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.

  • Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire [ Time Frame: Day 1 of 1-day study ] [ Designated as safety issue: No ]
    The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).

  • Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of 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 ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.

  • FEV1 and FVC, Pre-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).

  • FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).

  • FEV1 and FVC, Post-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day visit ] [ Designated as safety issue: No ]
    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).

  • FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).

  • Post-bronchodilator Reversibility Measures [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.

  • Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
  • Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
  • Number of Participants Who Completed the Highest Indicated Education Level or Grade [ Time Frame: Day 1 of 1-day study ] [ Designated as safety issue: No ]
  • Number of Participants With the Indicated Experience With Tobacco Smoking [ Time Frame: Day 1 of 1-day study ] [ Designated as safety issue: No ]
  • Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History [ Time Frame: Day 1 of 1-day study ] [ Designated as safety issue: No ]
    IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.


Enrollment: 1283
Study Start Date: April 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442468

  Show 47 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00442468     History of Changes
Other Study ID Numbers: ADC109043
Study First Received: March 1, 2007
Results First Received: December 2, 2009
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Bronchitis
Spirometry

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 25, 2014