- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00826748
Effect of Inhaled Steroids on Gene Expression in the Lungs - 2
January 2, 2018 updated by: Weill Medical College of Cornell University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10021
- Weill Cornell Medical College
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treated Smokers
The treatment with inhaled beclomethasone will be administered to this cohort 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.
|
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
Other Names:
|
NO_INTERVENTION: Non-Treated Smokers
This cohort will act as control and include healthy smokers who receive no treatment.
|
|
NO_INTERVENTION: Non-Smokers
This cohort will act as control and include healthy non-smokers who receive no treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14
Time Frame: 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.
|
The primary study endpoint is a change in the gene expression in the airway epithelium or alveolar macrophages of healthy smokers following treatment with beclomethasone.
Airway epithelium and alveolar macrophages are processed to yield high quality RNA.
Complementary DNA (cDNA) is transcribed from the RNA in vitro and the product is hybridized onto gene microarray chips.
The chip is then scanned and the image analyzed using the Affymetrix Microarray suite version 5 (MAS5) algorithm.
Using GeneSpring software the data is normalized and differential expression is determined by fold change (up or down regulation) of the individual genes by comparing the geometric mean expression value from the airway epithelium and alveolar macrophages obtained from Day 7 and Day 14 following initiation of therapy to baseline values.
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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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
January 21, 2009
First Submitted That Met QC Criteria
January 21, 2009
First Posted (ESTIMATE)
January 22, 2009
Study Record Updates
Last Update Posted (ACTUAL)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 2, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Beclomethasone
Other Study ID Numbers
- 0809009975
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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