Overview

Effect of Steroids on Gene Expression in the Healthy Smokers Lungs

Status:
Withdrawn
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD). The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium (alveolar macrophages) of healthy smokers develop characteristic gene expression changes that are different from that of nonsmokers. These gene expression changes include up- and down-regulation of genes in functional categories known to be relevant to the development of COPD. Administration of anti-inflammatory medications (inhaled steroids) in combination with long acting medications that open the airways (bronchodilators), are known to decrease the rate of acute exacerbations and improve the quality of life of individuals with COPD; however, the mechanisms underlying these beneficial effects of are poorly understood. This study will assess the effect of traditional therapy for COPD (inhaled corticosteroids, an anti-inflammatory medication, plus a bronchodilator, a medication that helps open the airways) on smoking-induced gene changes in airway epithelium and alveolar macrophages. Volunteer subjects will be evaluated by bronchoscopy to sample lung cells at 0, 7 and 14 days, with the therapy given at day 1 through day 7. The bronchoscopy aspects of this study will be covered by approved Weill-Cornell IRB protocol # 0005004439 (see below.) To participate in this protocol, the research subject will first be enrolled in Weill-IRB protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy", fulfilling the inclusion/exclusion criteria of that protocol. They will be invited to participate in this protocol only if they meet the additional inclusion/exclusion criteria of this protocol.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Weill Medical College of Cornell University
Treatments:
Beclomethasone
Bronchodilator Agents
Criteria
Inclusion Criteria:

Group A and B

- All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled
"Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with
Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"

- All study subjects should be able to provide informed consent

- Current smokers with 15-to 40 pack-year history

- All study individuals should be healthy as per protocol #0005004439 entitled
"Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with
Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"

Group C

- All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled
"Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with
Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"

- All study subjects should be able to provide informed consent

- All study individual should be healthy as per protocol #0005004439 entitled
"Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with
Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"

Exclusion Criteria:

Group A and B

- Smokers intending to quit smoking in the next 14 days.

- Individuals already receiving any lung related inhalers

- Females who are pregnant or nursing

Group C

Exclusion Criteria:

- Non-smokers who intend to start smoking in the next 14 days

- Individuals already receiving any lung related inhalers

- Females who are pregnant or nursing