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Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00454675
Enrollment
100
Registered
2007-04-02
Start date
2007-03-31
Completion date
2008-08-31
Last updated
2008-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Bronchitis, COPD

Keywords

Smokers, Chronic Bronchitis, Pulmonary Function Test Abnormalities, COPD

Brief summary

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

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.

Interventions

None listed

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Westside Family Medical Center, P.C.
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026