NCT00454675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 15, 2008

Status Verified

June 1, 2008

First QC Date

March 30, 2007

Last Update Submit

August 13, 2008

Conditions

Keywords

SmokersChronic BronchitisPulmonary Function Test AbnormalitiesCOPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westside Family Medical Center, P.C.

Kalamazoo, Michigan, 49009, United States

Location

MeSH Terms

Conditions

Bronchitis, ChronicPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gary E Ruoff, MD

    Westside Family Medical Center, P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 2, 2007

Study Start

March 1, 2007

Study Completion

August 1, 2008

Last Updated

August 15, 2008

Record last verified: 2008-06

Locations