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Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

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ClinicalTrials.gov Identifier: NCT02557958
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Azithromycin Drug: Placebo Early Phase 1

Detailed Description:

Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in the United States. It is projected to be the leading cause of death by 2020. As many as 24 million Americans are estimated to suffer from impaired lung function. Of those more than 12 million were actually diagnosed with COPD, and over 118,000 deaths were attributed to COPD in 2004.

COPD has been linked with an increased risk for lung cancer. Both airway obstruction, defined by abnormal pulmonary function tests (PFTs), and CT scan diagnosed emphysema were shown to be independent risk factors for lung cancer.

Treatment for COPD includes cessation of environmental exposures (i.e. smoking), dampening the inflammatory response, symptoms control and, for a small subgroup, surgical approaches and lung transplant. Nevertheless, the effectiveness of these treatment options to change the natural history of this disease is very limited. Recent evidence suggests a new role for macrolides as immune-modulators in patients with COPD, although the mechanisms are not clearly determined.

The investigators hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
Actual Study Start Date : January 2009
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Azithromycin
Azithromycin 250mg daily, single daily use for 8 weeks
Drug: Azithromycin
We hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.
Other Name: Zithromax

Placebo Comparator: Placebo
Placebo daily for 8 weeks
Drug: Placebo
We hypothesize that in patients with COPD, treatment with placebo will show NO change in inflammatory markers, transcription factor changes and lung function from baseline.




Primary Outcome Measures :
  1. Inflammatory markers [ Time Frame: outcome will be assessed up to two months post initial bronchoscopy ]
    Cytokines in BAL in pg/mL


Secondary Outcome Measures :
  1. transcription factor changes [ Time Frame: outcome will be assessed up to two months post initial bronchoscopy ]
    BAL cell differential in percentage

  2. Lung function changes [ Time Frame: outcome will be assessed up to two months post initial bronchoscopy ]
    Forced Vital Capacity (FVC)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Key Inclusion Criteria: List primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria).

    1. Patient must be 50 years old or older.
    2. Patient must have a smoking history of at least 20 pack-years
    3. Patient must have stable COPD, GOLD 0, I and/or IIA.
    4. CT of chest with evidence of emphysema
  • Key Exclusion Criteria: List primary criteria for study exclusion (i.e. do not need to enter entire list of inclusion criteria).

    1. FEV1 < 70%.
    2. Exacerbations (defined as use of oral steroids or antibiotics) in the previous month.
    3. Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
    4. Diabetes mellitus
    5. Renal disease
    6. Liver disease
    7. Lung cancer
    8. ETOH use of more than >6 beers >4 mixed drinks daily

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02557958     History of Changes
Other Study ID Numbers: 09-0769
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by NYU Langone Health:
COPD, pulmonary disease

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases