Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
1 other identifier
interventional
19
0 countries
N/A
Brief Summary
Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 chronic-obstructive-pulmonary-disease
Started Jan 2009
Longer than P75 for early_phase_1 chronic-obstructive-pulmonary-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 21, 2019
March 1, 2019
9.9 years
September 2, 2015
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammatory markers
Cytokines in BAL in pg/mL
outcome will be assessed up to two months post initial bronchoscopy
Secondary Outcomes (2)
transcription factor changes
outcome will be assessed up to two months post initial bronchoscopy
Lung function changes
outcome will be assessed up to two months post initial bronchoscopy
Study Arms (2)
Azithromycin
EXPERIMENTALAzithromycin 250mg daily, single daily use for 8 weeks
Placebo
PLACEBO COMPARATORPlacebo daily for 8 weeks
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient must be 50 years old or older.
- Patient must have a smoking history of at least 20 pack-years
- Patient must have stable COPD, GOLD 0, I and/or IIA.
- CT of chest with evidence of emphysema
You may not qualify if:
- FEV1 \< 70%.
- Exacerbations (defined as use of oral steroids or antibiotics) in the previous month.
- Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
- Diabetes mellitus
- Renal disease
- Liver disease
- Lung cancer
- ETOH use of more than \>6 beers \>4 mixed drinks daily
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27486204DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 23, 2015
Study Start
January 1, 2009
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 21, 2019
Record last verified: 2019-03