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RECRUITING
NCT03762395
PHASE2

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-02-08

Completion Date

2030-01-30

Last Updated

2025-06-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

CXA-10

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

DRUG

Matching 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