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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
6 weeks of treatment with 150 mg/day of orally administered CXA-10
6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGChange in Methacholine challenge dose per spirometry
To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose
Time frame: Through study completion, up to 18 weeks
Changes in pre-bronchodilator FEV1 per spirometry
To determine the efficacy of CXA-10 by improving FEV1
Time frame: Through study completion, up to 18 weeks
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