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| Sponsored by: |
Weill Medical College of Cornell University |
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| Information provided by: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00826748 |
Purpose
The purpose of this study is to assess the effect of inhaled fluticasone (an inhaled corticosteroid) on the pattern of the lung airway epithelium and alveolar macrophages gene expression of healthy smokers. The investigators hypothesize that the administration of fluticasone will result in reversibility of some of the airway epithelium and alveolar macrophage gene expression changes induced by cigarette smoking.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: fluticasone 220 mcg |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Factorial Assignment |
| Official Title: | Effect of Inhaled Steroids on Gene Expression in the Lungs of Healthy Smokers |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Group A will receive 440mcg of fluticasone twice a day from Day 1 to Day 7 via a metered dose inhaler (Flovent HFA 220) delivering 220 mcg per puff. The dose will be 1 puff twice a day for 7 days.
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Drug: fluticasone 220 mcg
a metered dose inhaler (Flovent HFA 220) delivering 220 micrograms of fluticasone per puff.
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2: No Intervention
Group B will act as control and include healthy smokers who receive no treatment.
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3: No Intervention
Group C will act as control and include healthy non-smokers who receive no treatment.
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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, Ben G. Harvey, MD or authorized representative will obtain consent from individuals for this study. Once enrolled, smokers will be randomized to either the Group A [880 micrograms (mcg) of Fluticasone ; 2 puffs twice a day (each puff delivers 220 mcg) for 7 days] or Group B (no treatment). Fluticasone is available as a metered dose inhaler [Flovent (GlaxoSmithKline)] delivering 44, 110 and 220 micrograms (mcg) of fluticasone per one puff. We will be using Flovent HFA (GlaxoSmithKline), which delivers 220 mcg per puff. Flovent will be provided free by GlaxoSmithKline, a pharmaceutical company. 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 Timothy O'Connor, 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 Flovent 220 MDI (metered dose inhaler). Non-smokers, defined as individuals who have never smoked, will be part of Group C. Group C will act as control like Group B and receive no treatment. For Group A, Group B and Group C participants, 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. Any given subject will only have up to 4 bronchoscopies under the IRB approved protocol #0005004439.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Group A and B
Inclusion Criteria:
Exclusion Criteria:
Group C
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Ben-Gary Harvey, MD | Weill Cornell Medical College |
More Information
| Responsible Party: | Weill Cornell Medical College ( Ben-Gary Harvey ) |
| Study ID Numbers: | 0809009975 |
| Study First Received: | January 21, 2009 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00826748 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
COPD inhaled steroids gene expression smoker's lungs |
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Anti-Inflammatory Agents Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Anti-Asthmatic Agents Fluticasone |
Anti-Allergic Agents Peripheral Nervous System Agents Healthy Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
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Anti-Inflammatory Agents Respiratory System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases |
Autonomic Agents Lung Diseases Therapeutic Uses Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
