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

NCT00442468 | Completed Results

• 1 other identifier: ADC109043
• Study Type: observational
• Target: 1,283
• Locations: 1 country
• Sites: 47

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Chronic Bronchitis; Spirometry

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  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

  Day 1 of a 1-day study

Study Arms (1)

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.

Interventions

Non-interventional study. OTHER

This is a non-interventional (no drug treatment administered), prevalence (observational) study.

All participants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (47)

GSK Investigational Site

Highlands Ranch, Colorado, 80130, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

Clearwater, Florida, 33756, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Largo, Florida, 33770, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

Gillespie, Illinois, 62033, United States

Location

GSK Investigational Site

Vernon Hills, Illinois, 60061, United States

Location

GSK Investigational Site

Elkhart, Indiana, 46515, United States

Location

GSK Investigational Site

Evansville, Indiana, 47711, United States

Location

GSK Investigational Site

Arkansas City, Kansas, 67005, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Kalamazoo, Michigan, 49009, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55414, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55904, United States

Location

GSK Investigational Site

Nixa, Missouri, 65714, United States

Location

GSK Investigational Site

Missoula, Montana, 59808, United States

Location

GSK Investigational Site

Fremont, Nebraska, 68025, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Mooresville, North Carolina, 28117, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

Location

GSK Investigational Site

Sylva, North Carolina, 28779, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Beachwood, Ohio, 44122, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45224, United States

Location

GSK Investigational Site

Columbus, Ohio, 43215, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Dayton, Ohio, 45439, United States

Location

GSK Investigational Site

Kettering, Ohio, 45429, United States

Location

GSK Investigational Site

Yukon, Oklahoma, 73099, United States

Location

GSK Investigational Site

Clairton, Pennsylvania, 15205, United States

Location

GSK Investigational Site

Harleysville, Pennsylvania, 19438, United States

Location

GSK Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29309, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Harleysville, Tennessee, 37087, United States

Location

GSK Investigational Site

Milan, Tennessee, 38358, United States

Location

GSK Investigational Site

Plano, Texas, 75093, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Gig Harbor, Washington, 98335, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 19757984 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 10, 2013
• Results First Posted: January 7, 2010

Record last verified: 2012-10

Locations

US (47)