Clinical trial

Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma

Recruiting now · Phase 2 · 1 countries · Registry ID NCT03762395

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionAsthma, Obesity

Full registry criteria

Inclusion Criteria: 1. 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. 2. BMI \>/= 30 3. 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 4. 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: 1. Respiratory tract infection within the last 4 weeks 2. Oral or systemic corticosteroid burst within the last 4 weeks 3. Asthma-related hospitalization within the last 6 weeks 4. Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma 5. Asthma-related ER visit within the previous 4 weeks 6. Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years

Treatments and study arms

CXA-10

Drug

6 weeks of treatment with 150 mg/day of orally administered CXA-10

Matching Placebo

Drug

6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)

Primary outcomes

Change in Methacholine challenge dose per spirometryThrough study completion, up to 18 weeks

To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose

Changes in pre-bronchodilator FEV1 per spirometryThrough study completion, up to 18 weeks

To determine the efficacy of CXA-10 by improving FEV1

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States

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Asthma ResearchContact

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