Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments azithromycin, placebo
Sponsor New York University School of Medicine
Start date January 2009
End date December 2020
Trial size 19 participants
Trial identifier NCT02557958, 09-0769

Summary

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Azithromycin 250mg daily, single daily use for 8 weeks
azithromycin Zithromax
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 Comparator)
Placebo daily for 8 weeks
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 Outcomes

Measure
Inflammatory markers
time frame: outcome will be assessed up to two months post initial bronchoscopy

Secondary Outcomes

Measure
transcription factor changes
time frame: outcome will be assessed up to two months post initial bronchoscopy
Lung function changes
time frame: outcome will be assessed up to two months post initial bronchoscopy

Eligibility Criteria

Male or female participants at least 50 years old.

- 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

Additional Information

Official title Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.