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Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02557958
Enrollment
19
Registered
2015-09-23
Start date
2009-01-31
Completion date
2018-12-31
Last updated
2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, pulmonary disease

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.

Interventions

DRUGAzithromycin

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.

DRUGPlacebo

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory markersoutcome will be assessed up to two months post initial bronchoscopyCytokines in BAL in pg/mL

Secondary

MeasureTime frameDescription
transcription factor changesoutcome will be assessed up to two months post initial bronchoscopyBAL cell differential in percentage
Lung function changesoutcome will be assessed up to two months post initial bronchoscopyForced Vital Capacity (FVC)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026