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Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

NCT ID: NCT00454675

Last Updated: 2008-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-08-31

Brief Summary

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To determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.

Detailed Description

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The incident of COPD is dramatically increasing while other chronic disease states are decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD. Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function tests. It is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.

Conditions

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Chronic Bronchitis COPD

Keywords

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Smokers Chronic Bronchitis Pulmonary Function Test Abnormalities COPD

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Subjects must sign a written informed consent.
2. Enrollment population would include males and females 40 years of age to 80 years of age.
3. Current history or past history of smoking at least 10 pack years of cigarettes.
4. Patients to satisfy the diagnosis of chronic bronchitis.
5. Non-smokers will be allowed in the control group

Exclusion Criteria

1. Chronic infections such as TB or other infections of the lungs.
2. Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs.
3. Any previous lung diseases such as pneumoconiosis.
4. Previous accidents or surgery which would involve the lungs or the ribcage.
5. Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids.
6. Asthma patients or other patients with allergies that may affect pulmonary function test will be excluded.
7. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
8. Pregnant woman will not be allowed
9. Current participation in a research study or within the last 30 days.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Westside Family Medical Center, P.C.

OTHER

Sponsor Role lead

Responsible Party

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Westside Family Medical Center, P.C.

Principal Investigators

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Gary E Ruoff, MD

Role: PRINCIPAL_INVESTIGATOR

Westside Family Medical Center, P.C.

Locations

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Westside Family Medical Center, P.C.

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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COPD-2006-01

Identifier Type: -

Identifier Source: org_study_id