Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

NYU Langone Health

Status and phase

Completed

Early Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Placebo

Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT02557958

09-0769

Details and patient eligibility

About

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

Full 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.

Enrollment

19 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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