Clinical trial NCT02557958: Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
Official title: Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, pulmonary disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

Detailed 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Inflammatory markers
timeFrame: outcome will be assessed up to two months post initial bronchoscopy
Secondary outcomes:
measure: transcription factor changes
timeFrame: outcome will be assessed up to two months post initial bronchoscopy
measure: Lung function changes
timeFrame: outcome will be assessed up to two months post initial bronchoscopy
Other outcomes:
Locations:
Study officials:
References:
citation: Segal LN, Clemente JC, Wu BG, Wikoff WR, Gao Z, Li Y, Ko JP, Rom WN, Blaser MJ, Weiden MD. Randomised, double-blind, placebo-controlled trial with azithromycin selects for anti-inflammatory microbial metabolites in the emphysematous lung. Thorax. 2017 Jan;72(1):13-22. doi: 10.1136/thoraxjnl-2016-208599. Epub 2016 Aug 2.