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

NCT ID: NCT03762395

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2030-01-30

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 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.

Conditions

Asthma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CXA-10

Administered orally, continuously, and daily for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Drug will be dispensed at Visit 4.

Group Type: EXPERIMENTAL

CXA-10

Intervention Type: DRUG

6 weeks of treatment with 150 mg/day of orally administered CXA-10

Matching Placebo

Administered orally, daily, and continuously for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Placebo will be dispensed at Visit 4.

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)

Interventions

CXA-10

6 weeks of treatment with 150 mg/day of orally administered CXA-10

Intervention Type: DRUG

Matching Placebo

6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)

Intervention Type: DRUG

Other Intervention Names

10-nitro-9(E)-octadec-9-enoic acid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Holguin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver- Anschutz Medical Campus

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Asthma Research

Role: CONTACT

asthmaresearch@ucdenver.edu

1 (844) 365-0852

Facility Contacts

Asthma Research

Role: primary

844-365-0852

Other Identifiers

5R01HL132550-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R61HL157069-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0510; 21-3959

Identifier Type: -

Identifier Source: org_study_id