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

Launched by UNIVERSITY OF COLORADO, DENVER · Nov 30, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CXA-10 for obese adults with asthma. The main goal is to see if CXA-10 can help reduce inflammation in the body and lungs, which can worsen asthma symptoms in people who are overweight. The trial will compare the effects of this treatment with a placebo (a substance with no active ingredients) to determine its safety and effectiveness. Researchers believe that CXA-10 may help improve breathing and reduce asthma flare-ups by addressing the inflammation caused by obesity.

To participate in this study, individuals must be between 18 and 65 years old, have a body mass index (BMI) of 30 or higher, and have been diagnosed with asthma for more than six months. They should also be regularly using asthma medications like inhaled corticosteroids. Participants should not have had recent serious asthma issues or infections, and current smokers or those who quit within the last year are not eligible. If you join the trial, you will receive either the treatment or placebo, and your health will be monitored throughout the study. This research could lead to better treatment options for asthma in people with obesity.

Gender

ALL

Eligibility 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