Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557958
• Other study ID #: 09-0769
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2009
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Azithromycin
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.
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers	Cytokines in BAL in pg/mL	outcome will be assessed up to two months post initial bronchoscopy
Secondary	transcription factor changes	BAL cell differential in percentage	outcome will be assessed up to two months post initial bronchoscopy
Secondary	Lung function changes	Forced Vital Capacity (FVC)	outcome will be assessed up to two months post initial bronchoscopy