Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

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.

Study Overview

• Status: Completed
• Conditions: COPD; Chronic Bronchitis

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Westside Family Medical Center, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Westside Family Medical Center, P.C.
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Gary E Ruoff, MD, Westside Family Medical Center, P.C.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: March 30, 2007
• First Submitted That Met QC Criteria: March 30, 2007
• First Posted (Estimate): April 2, 2007

Study Record Updates

• Last Update Posted (Estimate): August 15, 2008
• Last Update Submitted That Met QC Criteria: August 13, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: COPD; Chronic Bronchitis; Smokers; Pulmonary Function Test Abnormalities
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: COPD-2006-01