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Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Westside Family Medical Center, P.C.
ClinicalTrials.gov Identifier:
NCT00454675
First received: March 30, 2007
Last updated: August 13, 2008
Last verified: June 2008
History of Changes
  Purpose

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
Chronic Bronchitis
COPD

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Westside Family Medical Center, P.C.:

Estimated Enrollment: 100
Study Start Date: March 2007
Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454675

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

No publications provided

Responsible Party: Gary E. Ruoff, M.D., Westside Family Medical Center, P.C.
ClinicalTrials.gov Identifier: NCT00454675     History of Changes
Other Study ID Numbers: COPD-2006-01
Study First Received: March 30, 2007
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Westside Family Medical Center, P.C.:
Smokers
Chronic Bronchitis
Pulmonary Function Test Abnormalities
COPD

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013