Effect of Inhaled Steroids on Gene Expression in the Lungs - 2
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2018 |
| Start Date: | November 2010 |
| End Date: | December 2014 |
Effect of Inhaled Steroids on Gene Expression in the Lungs of Healthy Smokers
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.
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.
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.
#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.
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
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