Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Early Phase 1CompletedNCT02557958

NYU Langone Health19 enrolled

Overview

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

AzithromycinDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

Inflammatory markers

Cytokines in BAL in pg/mL

Time frame: outcome will be assessed up to two months post initial bronchoscopy

Secondary Outcomes

transcription factor changes

BAL cell differential in percentage

Time frame: outcome will be assessed up to two months post initial bronchoscopy

Lung function changes

Forced Vital Capacity (FVC)

Time frame: outcome will be assessed up to two months post initial bronchoscopy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.