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

Obesity Clinical Trial

— ALMA; LIMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03762395
• Other study ID #: 19-0510; 21-3959
• Secondary ID: 5R01HL132550-031
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2023
• Est. completion date: January 30, 2030

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Asthma Research
• Phone: 1 (844) 365-0852
• Email: asthmaresearch[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2030
• Est. primary completion date: November 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

Drug:
• CXA-10
6 weeks of treatment with 150 mg/day of orally administered CXA-10
• Matching Placebo
6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Methacholine challenge dose per spirometry	To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose	Through study completion, up to 18 weeks
Primary	Changes in pre-bronchodilator FEV1 per spirometry	To determine the efficacy of CXA-10 by improving FEV1	Through study completion, up to 18 weeks