Evaluating a new treatment for asthma in obese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.