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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.




Inclusion Criteria: 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 Exclusion Criteria: 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

Type of Study



CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Fernando Holguin,  MD

Fernando Holguin, MD

Study ID

Protocol Number: 21-3959

More information available at NCT03762395

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