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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Azithromycin Drug: Placebo||Early Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Azithromycin 250mg daily, single daily use for 8 weeks
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
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.
- Inflammatory markers [ Time Frame: outcome will be assessed up to two months post initial bronchoscopy ]Cytokines in BAL in pg/mL
- transcription factor changes [ Time Frame: outcome will be assessed up to two months post initial bronchoscopy ]BAL cell differential in percentage
- Lung function changes [ Time Frame: outcome will be assessed up to two months post initial bronchoscopy ]Forced Vital Capacity (FVC)