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

March 30, 2007
August 13, 2008
March 2007
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Complete list of historical versions of study NCT00454675 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
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Probability Sample

Primary care

  • Chronic Bronchitis
  • COPD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2008
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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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00454675
COPD-2006-01
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Gary E. Ruoff, M.D., Westside Family Medical Center, P.C.
Westside Family Medical Center, P.C.
GlaxoSmithKline
Principal Investigator: Gary E Ruoff, MD Westside Family Medical Center, P.C.
Westside Family Medical Center, P.C.
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP