Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

COPD Clinical Trial

Official title:

Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454675
• Other study ID #: COPD-2006-01
• Status: Completed
• Phase: N/A
• First received: March 30, 2007
• Last updated: August 13, 2008
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: June 2008
• Source: Westside Family Medical Center, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• COPD

Locations

Country	Name	City	State
United States	Westside Family Medical Center, P.C.	Kalamazoo	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Westside Family Medical Center, P.C.	GlaxoSmithKline

Country where clinical trial is conducted

United States,