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Lipid Mediator

Anti-Inflammatory Lipid Mediator for Asthma (ALMA; LIMA Trial)

Phase 2
Recruiting
Led By Fernando Holguin, MD, MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients, 18 to 65 years old
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
Must not have
Oral or systemic corticosteroid burst within the last 4 weeks
Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 18 weeks
Awards & highlights

Summary

This trial will study whether a synthetic nitro-fatty acid (CXA-10) can help suppress the systemic and airway inflammation that contributes to the obese asthmatic phenotype.

Who is the study for?
Adults aged 18-65 with obesity (BMI ≥30) and asthma, using regular inhaled corticosteroids or other long-term asthma medications. Women must be non-pregnant, post-menopausal, surgically sterile, or agree to use contraception. Excluded are those recently hospitalized for asthma, had a respiratory infection or steroid treatment within the last month, severe asthmatics with frequent exacerbations, or current/recent smokers.Check my eligibility
What is being tested?
The trial is testing CXA-10's effectiveness against placebo in reducing inflammation in obese adults with asthma. It's a Phase 2 study where participants will receive either the synthetic nitro-fatty acid CXA-10 or a placebo without knowing which one they're getting to compare outcomes.See study design
What are the potential side effects?
While specific side effects of CXA-10 aren't listed here, similar anti-inflammatory drugs can cause gastrointestinal issues like nausea and diarrhea; headaches; potential allergic reactions; fatigue; and possibly affect liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with asthma for over 6 months and respond to asthma medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken any corticosteroids in the last 4 weeks.
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I have had 3 or more severe asthma attacks in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Methacholine challenge dose per spirometry
Changes in pre-bronchodilator FEV1 per spirometry

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CXA-10Experimental Treatment1 Intervention
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 II: Matching PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CXA-10
2014
Completed Phase 2
~140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for asthma include inhaled corticosteroids, beta-2 agonists, leukotriene modifiers, and biologics. Inhaled corticosteroids reduce inflammation by inhibiting cytokine production. Beta-2 agonists relax airway muscles, improving airflow. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Biologics target specific immune pathways to reduce inflammation. Treatments like CXA-10, a synthetic nitro-fatty acid, work by modulating adipokine and cytokine expression, reducing systemic and pulmonary inflammation. This is crucial for asthma patients as it addresses the underlying inflammation, potentially reducing the frequency and severity of asthma attacks and improving overall lung function.
Agonist-induced lipoxin A4 generation: detection by a novel lipoxin A4-ELISA.Extracellular Adenosine Diphosphate Stimulates CXCL10-Mediated Mast Cell Infiltration Through P2Y1 Receptor to Aggravate Airway Inflammation in Asthmatic Mice.A combination of LCPUFA ameliorates airway inflammation in asthmatic mice by promoting pro-resolving effects and reducing adverse effects of EPA.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,812 Total Patients Enrolled
278 Trials studying Asthma
112,930 Patients Enrolled for Asthma
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,890 Total Patients Enrolled
59 Trials studying Asthma
8,597 Patients Enrolled for Asthma
University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,200 Total Patients Enrolled
20 Trials studying Asthma
2,925 Patients Enrolled for Asthma

Media Library

CXA-10 (Lipid Mediator) Clinical Trial Eligibility Overview. Trial Name: NCT03762395 — Phase 2
Asthma Research Study Groups: CXA-10, Matching Placebo
Asthma Clinical Trial 2023: CXA-10 Highlights & Side Effects. Trial Name: NCT03762395 — Phase 2
CXA-10 (Lipid Mediator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03762395 — Phase 2
Asthma Patient Testimony for trial: Trial Name: NCT03762395 — Phase 2
~40 spots leftby Nov 2029