Primary aim includes: To determine the efficacy of CXA-10 in reducing bronchial responsiveness, determined by the change in methacholine dose necessary to achieve a 20% reduction in FEV1 from baseline (PC20) Secondary aims include: - To investigate the effect of CXA-10 on differential gene expression in fresh airway epithelial cells Exploratory aims include: - To explore the efficacy of CXA-10 in improving lung function measured by FEV1, FEV1/FVC ratio and FEV1 % reversal and exhaled nitric oxide (FeNO) concentrations - To explore the efficacy of CXA-10 in improving asthma control using the Asthma Control Questionnaire (ACQ) - To explore the effect of CXA-10 on adipokine/cytokines plasma concentrations Safety aims include: - To assess the safety of 12 weeks of treatment with 150mg/day of orally administered CXA-10 in adult obese asthmatic subjects
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 (FA) (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. We hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics. This study will consist of 24 weeks (12 weeks placebo treatment and 12 weeks of CXA-10 treatment) in a randomized crossover fashion. There will be an approximate 4 week washout period.More
Inclusion Criteria: 1) Adequate completion of informed consent process with written documentation. 2) Male and female patients, 18 to 65 years old. 3) 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 at Visit 0 and prior to first dose. 4) Body mass index (BMI)  30 kg/m2 5) 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 BD response to 4 puffs of albuterol or PC20 methacholine (16 mg) if <12% change post BD 6) 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 2 months; on a stable dose for the 4 weeks prior to Visit 0 Exclusion Criteria: 1) Respiratory tract infection within the last 4 weeks prior to Visit 0 2) Oral or injectable corticosteroid burst within the last 4 weeks prior to Visit 0 3) Asthma-related hospitalization within the last 6 weeks prior to Visit 0 4) Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma 5) Asthma-related emergency room visit within the previous 4 weeks prior to Visit 0 6) Current smoker (or any other form of nicotine use) or have former smokers that quit within the previous 1 year, or  10 pack years
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
University of Colorado Hospital
University of Pittsburgh Cancer Institute
Fernando Holguin, MD
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