Status:
RECRUITING
Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 syst...
Eligibility Criteria
Inclusion
- 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.
- BMI \>/= 30
- 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
- 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
- Respiratory tract infection within the last 4 weeks
- Oral or systemic corticosteroid burst within the last 4 weeks
- Asthma-related hospitalization within the last 6 weeks
- Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
- Asthma-related ER visit within the previous 4 weeks
- Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years
Key Trial Info
Start Date :
February 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03762395
Start Date
February 8 2023
End Date
January 30 2030
Last Update
June 10 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045