Effect of Inhaled Steroids on Gene Expression in the Lungs - 2
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Beclomethasone
Intervention description: The treatment with inhaled beclomethasone will be administered to Group A from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
Intervention MeSH terms: Beclomethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COPD; inhaled steroids; gene expression; smoker's lungs

Summary:

      The purpose of this study is to assess the effect of inhaled beclomethasone (an inhaled
      corticosteroid) on the pattern of the lung airway epithelium and alveolar macrophages gene
      expression of healthy smokers. We hypothesize that the administration of beclomethasone will
      result in reversibility of some of the airway epithelium and alveolar macrophage gene
      expression changes induced by cigarette smoking.
    

Eligibility criteria:

        Inclusion Criteria:

        All Smokers (Treated and Non-Treated)

          -  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"

        Non-Smokers

          -  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:

        All Smokers

          -  Smokers intending to quit smoking in the next 14 days.

          -  Individuals already receiving any lung related inhalers

          -  Females who are pregnant or nursing

        Non-Smokers

        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