Effect of Inhaled Steroids on Gene Expression in the Lungs - 2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00826748
First received: January 21, 2009
Last updated: October 15, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Beclomethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Effect of Inhaled Steroids on Gene Expression in the Lungs of Healthy Smokers

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Microarray chips are scanned and the image analyzed using the Affymatrix Microarray suite algorithm. The data is normalized and differential expression is determined by fold change of the individual genes. [ Time Frame: Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on screening ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Drug: Beclomethasone
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 Name: QVAR 80 HFA
No Intervention: 2
Group B will act as control and include healthy smokers who receive no treatment.
No Intervention: 3
Group C will act as control and include healthy non-smokers who receive no 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 Group A [320 micrograms (mcg) of beclomethasone; 2 puffs twice a day (each puff delivers 80 mcg) for 7 days] or Group B (no treatment). 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group A and B

  • 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"

Group C

  • 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:

Group A and B

  • Smokers intending to quit smoking in the next 14 days.
  • Individuals already receiving any lung related inhalers
  • Females who are pregnant or nursing

Group C

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826748

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Ann E Tilley, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00826748     History of Changes
Other Study ID Numbers: 0809009975
Study First Received: January 21, 2009
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
COPD
inhaled steroids
gene expression
smoker's lungs

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Beclomethasone
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014