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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Asthma, Obesity

In brief

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.

Key facts

Study ID

NCT03762395

Run by

University of Colorado, Denver

People needed

60

Starts

2023-02-08

Expected to finish

2030-01-30

Last updated by the study team

2025-06-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• BMI >/= 30
• 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
• 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

You may not qualify if…

• 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 requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
• Asthma-related ER visit within the previous 4 weeks
• Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.