Evaluating a new treatment for asthma in obese adults
Anti Inflammatory Lipid Mediators in Asthma: A Double Blind Placebo Control Cross Over, Proof of Concept Study of CXA-10 to Reduce Bronchial Hyperresponsiveness in Obese Asthmatics; Lipid Anti-Inflammatory Mediators in Asthma to Reduce Hyperresponsiveness in Obese Asthmatics
This study is testing a new treatment for asthma in obese adults to see if it can help reduce inflammation and improve their breathing.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03762395 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial investigates the efficacy and safety of CXA-10, a synthetic nitro-fatty acid, in treating obese adults with asthma. The study employs a double-blind, placebo-controlled crossover design to assess how CXA-10 can suppress systemic and airway inflammation associated with obesity-related asthma. Participants will receive either the treatment or a matching placebo, with the aim of demonstrating improvements in asthma symptoms and overall lung function. The trial focuses on understanding the signaling actions of CXA-10 that may beneficially modulate inflammatory responses in this patient population.
Who should consider this trial
Good fit: Ideal candidates are obese adults aged 18 to 65 with a physician-diagnosed asthma and a stable treatment regimen.
Not a fit: Patients who are not obese or do not have a diagnosis of asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve asthma control and reduce exacerbations in obese patients.
How similar studies have performed: Other studies have shown promising results with similar anti-inflammatory approaches in asthma, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Fernando Holguin, MD, MPH — University of Colorado Denver- Anschutz Medical Campus
- Study coordinator: Asthma Research
- Email: asthmaresearch@ucdenver.edu
- Phone: 1 (844) 365-0852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.