Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

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

Detailed Description
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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.

Official Title
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Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: List primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria). Patient must be 50 years old or older. Patient must have a smoking history of at least 20 pack-years Patient must have stable COPD, GOLD 0, I and/or IIA. 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). FEV1 < 70%. Exacerbations (defined as use of oral steroids or antibiotics) in the previous month. Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure. Diabetes mellitus Renal disease Liver disease Lung cancer ETOH use of more than >6 beers >4 mixed drinks daily

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin<br>Azithromycin 250mg daily, single daily use for 8 weeks | Drug: Azithromycin<br>* 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.<br>* Other names: Zithromax;|
| Placebo Comparator: Placebo<br>Placebo daily for 8 weeks | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | Cytokines in BAL in pg/mL | outcome will be assessed up to two months post initial bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transcription factor changes | BAL cell differential in percentage | outcome will be assessed up to two months post initial bronchoscopy | 
| Lung function changes | Forced Vital Capacity (FVC) | outcome will be assessed up to two months post initial bronchoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, pulmonary disease