Actively Recruiting
Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma
Led by University of Colorado, Denver · Updated on 2025-06-10
60
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics.
CONDITIONS
Official Title
Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Able to provide written informed consent
- Female participants must be post-menopausal, surgically sterile, or use acceptable contraception with a negative pregnancy test if of childbearing potential
- Body mass index (BMI) of 30 or higher
- Asthma diagnosis for more than 6 months
- Baseline pre-bronchodilator FEV1 between 50 and 95% predicted
- Either a 12% or greater bronchodilator response to albuterol or methacholine challenge if under 12% change post-bronchodilator
- Regular use of inhaled corticosteroids (up to 1000 mcg/day fluticasone or equivalent), long-acting beta agonists, and/or long-acting muscarinic antagonists for at least 3 months
- Stable asthma medication dose for 4 weeks before study start
You will not qualify if you...
- Respiratory tract infection within the last 4 weeks
- Oral or systemic corticosteroid burst within the last 4 weeks
- Asthma-related hospitalization within the last 6 weeks
- Three or more asthma exacerbations treated with systemic corticosteroids in the past year
- Asthma-related emergency room visit within the last 4 weeks
- Current smokers or former smokers who quit less than 1 year ago or have a history of 10 or more pack years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Asthma Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here