Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2018-12-31

Brief Summary

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Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Azithromycin

Azithromycin 250mg daily, single daily use for 8 weeks

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

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.

Placebo

Placebo daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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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

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No