RecruitingPhase 2NCT03762395

Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma

Anti Inflammatory Lipid Mediators in Asthma: A Double Blind Placebo Control Cross Over, Proof of Concept Study of CXA-10 to Reduce Bronchial Hyperresponsiveness in Obese Asthmatics; Lipid Anti-Inflammatory Mediators in Asthma to Reduce Hyperresponsiveness in Obese Asthmatics


Sponsor

University of Colorado, Denver

Enrollment

60 participants

Start Date

Feb 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying naturally occurring anti-inflammatory substances in the body (called lipid mediators) to understand how they may help reduce airway inflammation in obese people with asthma. **You may be eligible if...** - You have been diagnosed with asthma for at least 6 months - You are 18–65 years old - Your BMI (body mass index) is 30 or higher (considered obese) - Your lung function test falls within a specific range (FEV1 between 50–95% of predicted) - You use a bronchodilator (rescue inhaler) that improves your breathing - You can agree to use contraception if you could become pregnant **You may NOT be eligible if...** - You are a smoker or have smoked heavily in the past - You are pregnant or breastfeeding - You have other lung diseases (besides asthma) or severe health conditions - You are on certain medications that could interact with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCXA-10

6 weeks of treatment with 150 mg/day of orally administered CXA-10

DRUGMatching Placebo

6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)


Locations(1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

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NCT03762395


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