Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

This study has been completed.

First Received: March 30, 2007 Last Updated: August 13, 2008 History of Changes

Sponsors and Collaborators:	Westside Family Medical Center, P.C. GlaxoSmithKline
Information provided by:	Westside Family Medical Center, P.C.
ClinicalTrials.gov Identifier:	NCT00454675

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:	Ecologic or Community, Prospective
Official Title:	Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

Resource links provided by NLM:

MedlinePlus related topics: Bronchitis

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:

Subjects must sign a written informed consent.
Enrollment population would include males and females 40 years of age to 80 years of age.
Current history or past history of smoking at least 10 pack years of cigarettes.
Patients to satisfy the diagnosis of chronic bronchitis.
Non-smokers will be allowed in the control group

Exclusion Criteria:

Chronic infections such as TB or other infections of the lungs.
Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs.
Any previous lung diseases such as pneumoconiosis.
Previous accidents or surgery which would involve the lungs or the ribcage.
Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids.
Asthma patients or other patients with allergies that may affect pulmonary function test will be excluded.
Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
Pregnant woman will not be allowed
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:	Westside Family Medical Center, P.C. ( Gary E. Ruoff, M.D. )
Study ID Numbers:	COPD-2006-01
Study First Received:	March 30, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00454675 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Westside Family Medical Center, P.C.:

Smokers
Chronic Bronchitis
Pulmonary Function Test Abnormalities
COPD

Study placed in the following topic categories:

Acute Disease
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Bronchial Diseases
Lung Diseases
Bronchitis
Congenital Abnormalities
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Acute Disease
Bronchitis, Chronic
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Infections

Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 10, 2009