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ALMA: Anti Inflammatory Lipid Mediators in Asthma- A double blind, randomized, placebo controlled, crossover, proof of concept study of CXA-10 to reduce bronchial hyperresponsiveness in obese asthmatics

Primary Objective

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

Study category: Respiratory

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Description

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.

Details
Age

Adult

Eligibility

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) &#61619; 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 &#61619; 10 pack years

Phase

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.

Type of Study

Treatment

Scope

National

Locations

University of Colorado Hospital
University of Pittsburgh Cancer Institute

Principal Investigator
Fernando Holguin,  MD

Fernando Holguin, MD

Study ID

Protocol Number: 19-0510

ClinicalTrials.gov: NCT03762395

Categories

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