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Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT00532584

Effect of Steroids on Gene Expression in the Healthy Smokers Lungs

A Phase 4 study testing Beclomethasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD). The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium (alveolar macrophages) of healthy smokers develop characteristic gene expression changes that are different from that of nonsmokers. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Beclomethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2011to Aug 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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"

Who cannot join

  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Weill Cornell Medical College

    New York, New York, 10021

Other trials in United States

About this study

Official title: Effect of Inhaled Steroids in Combination With a Long Acting Bronchodilator on Gene Expression in the Lungs of Healthy Smokers

Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD). The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium (alveolar macrophages) of healthy smokers develop characteristic gene expression changes that are different from that of nonsmokers. These gene expression changes include up- and down-regulation of genes in functional categories known to be relevant to the development of COPD. Administration of anti-inflammatory medications (inhaled steroids) in combination with long acting medications that open the airways (bronchodilators), are known to decrease the rate of acute exacerbations and improve the quality of life of individuals with COPD; however, the mechanisms underlying these beneficial effects of are poorly understood. This study will assess the effect of traditional therapy for COPD (inhaled corticosteroids, an anti-inflammatory medication, plus a bronchodilator, a medication that helps open the airways) on smoking-induced gene changes in airway epithelium and alveolar macrophages. Volunteer subjects will be evaluated by bronchoscopy to sample lung cells at 0, 7 and 14 days, with the therapy given at day 1 through day 7. The bronchoscopy aspects of this study will be covered by approved Weill-Cornell IRB protocol # 0005004439 (see below.)

To participate in this protocol, the research subject will first 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", fulfilling the inclusion/exclusion criteria of that protocol. They will be invited to participate in this protocol only if they meet the additional inclusion/exclusion criteria of this protocol.

Read the detailed description

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.

Background. Chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, occurs in 15 to 20% of individuals who smoke, and is a leading cause of disease and mortality in the US (1, 2). Cigarette smoking is found to be the cause of approximately 90% of the cases of COPD in the US (1, 2). The human lung airway epithelium receives the initial brunt of cigarette smoking, and the airway epithelium and alveolar macrophages play a central role in the development of COPD (3-6). Asymptomatic healthy smokers have increased rate of cell proliferation in the airway epithelium consistent with the concept that the airway epithelium of smokers undergoes molecular changes that precede the development of COPD (7). Similarly, smoking increases the number and activates the alveolar macrophages present in the alveoli of human lung leading to the release of various mediators involved in the pathogenesis of COPD (4, 6, 8, 9).

Assessment of human lung airway epithelium and alveolar macrophages gene expression of healthy smokers compared to healthy non-smoking individuals demonstrate that the epithelium of the large and the small airways and the alveolar macrophages up- and down-regulate a variety of genes relevant to the pathogenesis of COPD (10-15). The differential gene expression in the epithelium of smokers compared to nonsmokers comprises genes in various functions, including genes involved in inflammation, cell repair, cell differentiation, cell death, detoxification, and cell signaling. While the airway epithelium is target for the stress of cigarette smoking, alveolar macrophages (the pulmonary representative of the bone marrow-derived mononuclear phagocyte system) are activated by smoking, and release a variety of mediators that can injure the fragile lung structure (4, 6, 16). Thus, while the airway epithelium is injured by smoking, the alveolar macrophages contribute to the smoking-induced injury. Many studies in vitro and in vivo in animals and in humans demonstrate the role of the airway epithelium and alveolar macrophages in the development of COPD with the release of various pro-inflammatory mediators, and mediators involved in cell apoptosis, proteolysis, airway remodeling and obstruction contributing to the characteristic findings of inflammation and obstruction observed in the airways of individuals with COPD (3-9, 17, 18).

Beclomethasone is one of the medications that when administered by inhalation to individuals with moderate to severe COPD results in reduction of hospitalization by approximately 30%, increased quality of life, and a decreased in the reduction of lung function (19, 20). Interestingly, beclomethasone is one of the medications that when administered by inhalation following hospitalization with acute exacerbation to individuals with COPD, results in a lower re-hospitalization rate. The mechanisms by which inhaled steroids result in clinical improvement and increased quality of life in individuals with moderate to severe COPD and following acute exacerbations are poorly understood (19-24).

Being tested
Beclomethasone
Keywords
COPD, inhaled steroids, bronchodilator, gene expression, smoker's lungs
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BeclomethasoneDrug

    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

Study groups in NCT00532584
Study groupRoleWhat they receive
treatment with inhaled beclomethasoneExperimentalThe 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
Receives: Drug: Beclomethasone
Control - healthy smokersNo interventionGroup B will act as control and include healthy smokers who receive no treatment.
control - healthy non-smokersNo interventionGroup C will act as control and include healthy non-smokers who receive no treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microarray chips are scanned and analyzed using Affymatrix Microarray suite version 5 (MAS5). Using GeneSpring software the data is normalized and differential expression is determined using alveolar macrophages.

    Measured: Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on screening

Secondary outcomes (1)
  1. St. George Respiratory questionnaire

    Measured: To be completed on Screening Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2007 (estimated)
  2. Study startFeb 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Why it stopped: Study not initiated due to funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532584
Sponsor's protocol ID
0709009398
Status last verified
May 2016
First submitted
19 Sep 2007
Last updated
4 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beclomethasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microarray chips are scanned and analyzed using Affymatrix Microarray suite version 5 (MAS5). Using GeneSpring software the data is normalized and differential expression is determined using alveolar macrophages. (time frame: Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.

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