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

NCT00826748 | Terminated Phase 4 Results DMC

• 1 other identifier: 0809009975
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; inhaled steroids; gene expression; smoker's lungs

Outcome Measures

Primary Outcomes (1)

• Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14

  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.

  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.

Study Arms (3)

Treated Smokers

EXPERIMENTAL

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.

Drug: Beclomethasone

Non-Treated Smokers

NO INTERVENTION

This cohort will act as control and include healthy smokers who receive no treatment.

Non-Smokers

NO INTERVENTION

This cohort will act as control and include healthy non-smokers who receive no treatment.

Interventions

Beclomethasone DRUG

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

Also known as: QVAR 80 HFA

Treated Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Limitations and Caveats

The study could not completed as designed due to a lack of funding.

Results Point of Contact

• Title: Grace Mammen
• Organization: Weill Cornell Medicine

gwm2004@med.cornell.edu

646-962-2672

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: November 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 25, 2018
• Results First Posted: January 25, 2018

Record last verified: 2018-01

Locations

US (1)