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Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454675
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : August 15, 2008
Information provided by:
Westside Family Medical Center, P.C.

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.

Condition or disease
Chronic Bronchitis COPD

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis
Study Start Date : March 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454675

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United States, Michigan
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States, 49009
Sponsors and Collaborators
Westside Family Medical Center, P.C.
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Principal Investigator: Gary E Ruoff, MD Westside Family Medical Center, P.C.

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Responsible Party: Gary E. Ruoff, M.D., Westside Family Medical Center, P.C. Identifier: NCT00454675    
Other Study ID Numbers: COPD-2006-01
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: August 15, 2008
Last Verified: June 2008
Keywords provided by Westside Family Medical Center, P.C.:
Chronic Bronchitis
Pulmonary Function Test Abnormalities
Additional relevant MeSH terms:
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Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive