Participate in Research at CU Anschutz

Primary outcome: The primary aim is to determine the efficacy of CXA-10 in improving pre bronchodilator FEV1 from baseline, relative to placebo. Secondary outcomes: A) Methacholine testing is the key standard for determining bronchial hyperresponsivess. Our protocol uses a quadrupling dose, according to the standards proposed by the American Thoracic Society (ATS) (61), which meets all safety regulations (See Protection of Human Subjects). B) Asthma control, determined by the change in the Asthma Control Questionnaire (ACQ) score(62), relative to placebo.

The research plan is designed to test the beneficial metabolic and anti-inflammatory actions of an endogenously present class of modified fats, termed nitro-fatty acids. This project provides a novel precision pharmacology therapy, oral CXA-10, for the treatment of obese asthma, a disease that responds poorly to standard asthma medications and increases airway hyperreactivity. The study will leverage both clinical variables (lung function, asthma control questionnaire and bronchial hyperreactivity) as well as the use of gut, lung, nasal, plasma and urine samples as a translational research tool to better understand obesity-mediated changes in relation to how CXA-10 effects changes in gene expression and how –omics profiles are modified by CXA-10. We hypothesize that nitro-fatty acid-induced signaling and metabolic responses will improve lung function, asthma control and alleviate obesity-related airway hyperreactivity. Primary aim includes: To test this concept, a de-risked pleiotropic drug strategy will be evaluated by a blinded, placebo-controlled, crossover design Phase 2 proof of concept study: Aim #1 – Evaluate the clinical responses of obesity-associated asthma patients to the orally administered nitro-fatty acid, 10-nitro-octadeca-9-enoic acid (NO2-OA, CXA-10). The primary outcome of this clinical study will be a change in pre bronchodilator FEV1 from baseline. Aim #2 – Identify the downstream host and microbial gene expression and metabolic responses of subjects before and after oral CXA-10 administration. These clinical resources provide a unique opportunity to evaluate the responses of humans, as opposed to rodents, to electrophilic NO2-FA.