Pulmonary Disease, Chronic ObstructiveNCT00442468
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
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 47 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Non-interventional study.
- How many people
- 1,283 participants
- Where
- 47 sitesUnited States
- Study dates
- Apr 2007to Sep 2007
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Beachwood, Ohio, 44122
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Cincinnati, Ohio, 45224
GSK Investigational Site
Clairton, Pennsylvania, 15205
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Cumberland, Rhode Island, 02864
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Dayton, Ohio, 45439
GSK Investigational Site
Elkhart, Indiana, 46515
GSK Investigational Site
Evansville, Indiana, 47711
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fremont, Nebraska, 68025
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Gig Harbor, Washington, 98335
GSK Investigational Site
Gillespie, Illinois, 62033
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Harleysville, Pennsylvania, 19438
GSK Investigational Site
Harleysville, Tennessee, 37087
GSK Investigational Site
Highlands Ranch, Colorado, 80130
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
Largo, Florida, 33770
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Milan, Tennessee, 38358
GSK Investigational Site
Minneapolis, Minnesota, 55414
GSK Investigational Site
Missoula, Montana, 59808
GSK Investigational Site
Mooresville, North Carolina, 28117
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
Nixa, Missouri, 65714
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Rochester, Minnesota, 55904
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Sylva, North Carolina, 28779
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Union, South Carolina, 29309
GSK Investigational Site
Vernon Hills, Illinois, 60061
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Wichita, Kansas, 67207
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Yukon, Oklahoma, 73099
About this study
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
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).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Non-interventional study.
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis, Spirometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional study.Other
This is a non-interventional (no drug treatment administered), prevalence (observational) study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-interventional study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%
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).
Measured: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)
Secondary outcomes (24)
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale
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.
Measured: 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
The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Day 1 of a 1-day study
FEV1 and FVC, Pre-bronchodilator Spirometry Measures
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).
Measured: Day 1 of a 1-day study
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures
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).
Measured: Day 1 of a 1-day study
FEV1 and FVC, Post-bronchodilator Spirometry Measures
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).
Measured: Day 1 of a 1-day visit
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures
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).
Measured: Day 1 of a 1-day study
Post-bronchodilator Reversibility Measures
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.
Measured: Day 1 of a 1-day study
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness
Measured: Day 1 of a 1-day study
Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status
Measured: Day 1 of a 1-day study
Number of Participants Who Completed the Highest Indicated Education Level or Grade
Measured: Day 1 of 1-day study
Number of Participants With the Indicated Experience With Tobacco Smoking
Measured: Day 1 of 1-day study
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History
IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.
Measured: Day 1 of 1-day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,283 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442468
- Sponsor's protocol ID
- ADC109043
- Status last verified
- Oct 2012
- First submitted
- 1 Mar 2007
- Last updated
- 10 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 19757984
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00442468
- Acronym / sponsor ID
- ADC109043
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis, Spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,283 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Mar 2007 (estimated)
- Results
- Posted 7 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: Non-interventional study.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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional study.This is a non-interventional (no drug treatment administered), prevalence (observational) study. | Other | All participants |
Primary outcome
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).
24 secondary outcomes
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 of a 1-day study
FEV1 and FVC, Pre-bronchodilator Spirometry Measures
Time frame: Day 1 of a 1-day study
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures
Time frame: Day 1 of a 1-day study
FEV1 and FVC, Post-bronchodilator Spirometry Measures
Time frame: Day 1 of a 1-day visit
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures
Time frame: Day 1 of a 1-day study
Post-bronchodilator Reversibility Measures
Time frame: Day 1 of a 1-day study
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness
Time frame: Day 1 of a 1-day study
Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status
Time frame: Day 1 of a 1-day study
Number of Participants Who Completed the Highest Indicated Education Level or Grade
Time frame: Day 1 of 1-day study
Number of Participants With the Indicated Experience With Tobacco Smoking
Time frame: Day 1 of 1-day study
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History
Time frame: Day 1 of 1-day study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19757984Yawn 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.
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COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00442468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.