Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Early Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: Azithromycin

• Registration Number: NCT02557958
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo daily for 8 weeks
Azithromycin	Azithromycin	Azithromycin 250mg daily, single daily use for 8 weeks

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	outcome will be assessed up to two months post initial bronchoscopy	Cytokines in BAL in pg/mL

Secondary Outcome Measures

Name	Time	Method
transcription factor changes	outcome will be assessed up to two months post initial bronchoscopy	BAL cell differential in percentage
Lung function changes	outcome will be assessed up to two months post initial bronchoscopy	Forced Vital Capacity (FVC)