Clinical trial NCT00826748: Effect of Inhaled Steroids on Gene Expression in the Lungs - 2
Official title: Effect of Inhaled Steroids on Gene Expression in the Lungs of Healthy Smokers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
inhaled steroids
gene expression
smoker's lungs
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

Detailed description: The study will involve healthy smokers and non smokers enrolled in IRB approved 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". They will be invited to participate in this protocol only if they meet the additional inclusion/exclusion criteria of this protocol (see inclusion/exclusion criteria, section A6). The Principal Investigator, Ann E. Tilley, MD or authorized representative will obtain consent from individuals for this study. Once enrolled, smokers will be randomized to either the treated smoker group \[320 micrograms (mcg) of beclomethasone; 2 puffs twice a day (each puff delivers 80 mcg) for 7 days\] or non-treated group. Beclomethasone is available as a metered dose inhaler \[QVAR(TEVA Pharmaceuticals)\] delivering 80 micrograms (mcg) of beclomethasone per one puff. We will be using QVAR HFA (TEVA Pharmaceuticals), which delivers 80 mcg per puff. QVAR will be purchased by the Department of Genetic Medicine. It will be dispensed as appropriate to each research subject recruited in the trial at the Department of Genetic Medicine at 1305 York Ave YAB-13th floor, New York, NY 10021 (a facility of Weill Medical College). It will be stored at The Arthur \& Rochelle Belfer Gene Therapy Core Facility located at 515 E. 71st St., S901, New York, NY 10021 under the supervision of Stephen Kaminksy, PhD, Co-Director of the GMP (Good Manufacturing Practice). Each study individual will receive 1 package of the study medication which consists of 1 canister of QVAR 80 MDI (metered dose inhaler). Non-smokers, defined as individuals who have never smoked, will act as control like the Non-Treated Smoker group and receive no treatment. For all subjects, the screening, baseline bronchoscopy, and the bronchoscopies on Days 7±3 and 14±3 tests will be performed as part of IRB approved protocol #0005004439. No additional bronchoscopies will be performed under the current protocol.

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

Primary outcomes:
measure: Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14
timeFrame: Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ronald G Crystal, MD
role: PRINCIPAL_INVESTIGATOR
References: