NCT03762395PHASE2Recruiting

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

University of Colorado, Denver

Start Date

2/8/2023

Completion Date

1/30/2030

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 Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: 1. Adequate completion of informed consent process with written documentation. Male and female patients, 18 to 65 years old. Female subjects should be either post-menopausal or surgically sterile, or, if child-bearing potential (WOCP) should agree to use an acceptable method of contraception, for the duration of the study, with a negative pregnancy test prior to entering the study. 2. BMI \>/= 30 3. Diagnosis of asthma: based on previous physician diagnosis for \> 6 months, and baseline pre-bronchodilator (BD) FEV1 between 50 and 95% predicted with either a 12% or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16 mg) if \<12% change post BD 4. Regular treatment with inhaled corticosteroids (ICS) (up to 1000 mcg/day fluticasone/equivalent), long acting beta agonists (LABA), and/or long-acting muscarinic antagonists (LAMA), which can be combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0 Exclusion Criteria: 1. Respiratory tract infection within the last 4 weeks 2. Oral or systemic corticosteroid burst within the last 4 weeks 3. Asthma-related hospitalization within the last 6 weeks 4. Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma 5. Asthma-related ER visit within the previous 4 weeks 6. Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years

Interventions

DRUG

CXA-10

DRUG

Matching Placebo

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Conditions

AsthmaObesity

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States