Recruiting

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

ClinicalTrials.gov IDNCT03762395

PhasePHASE2

Enrollment60

SponsorUniversity of Colorado, Denver

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma, Obesity

About this study

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.

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)

Primary outcomes

Change in Methacholine challenge dose per spirometry (Through study completion, up to 18 weeks)
Changes in pre-bronchodilator FEV1 per spirometry (Through study completion, up to 18 weeks)

Eligibility information

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

Study locations

University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.