What side effects are associated with this type of intervention?

Common treatments for asthma that modulate inflammation, such as inhaled glucocorticoids and beta agonists, can have several side effects. Inhaled glucocorticoids may cause oral thrush, hoarseness, and, with long-term use, potential systemic effects like adrenal suppression and osteoporosis. Beta agonists, particularly when used frequently, can lead to tremors, palpitations, and hypokalemia. Other anti-inflammatory agents, like leukotriene modifiers, may cause headaches, gastrointestinal disturbances, and, rarely, neuropsychiatric events. It is important to monitor these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma, primarily focusing on reducing inflammation and managing symptoms. These include inhaled corticosteroids (ICS) like fluticasone, long-acting beta agonists (LABAs) such as salmeterol, and combination therapies like fluticasone/salmeterol. Additionally, leukotriene modifiers (e.g., montelukast) and biologics targeting specific inflammatory pathways (e.g., omalizumab, mepolizumab) have been approved. While there is no direct mention of FDA-approved treatments exactly like CXA-10, which modulates adipokine and cytokine expression, the broader category of anti-inflammatory and immunomodulatory therapies is well-represented in current asthma treatments.

What other types of research exist?

Promising novel alternatives to CXA-10 for asthma treatment include: 1) Exogenous pulmonary surfactants like calfactant, which have shown efficacy in reducing lung injury and inflammation. 2) Neutrophil elastase inhibitors, which target inflammatory pathways in the lungs. 3) Beta-2 agonists, which have been investigated for their role in reducing lung inflammation and improving respiratory function. These alternatives have shown potential in clinical trials and could be considered for asthma treatment in 2024.

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Lipid Mediator

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

Q: What is the mechanism of action of this treatment?

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.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 18 weeks

Awards & highlights

ALMA; LIMA Trial 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.

ALMA; LIMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I have been diagnosed with asthma for over 6 months and respond to asthma medication.

ALMA; LIMA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 18 weeks

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

ALMA; LIMA 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

0 / 2Eligibility criteria met

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

3,848 Previous Clinical Trials

47,818,202 Total Patients Enrolled

278 Trials studying Asthma

112,941 Patients Enrolled for Asthma

National Institutes of Health (NIH)NIH

2,720 Previous Clinical Trials

7,494,419 Total Patients Enrolled

59 Trials studying Asthma

8,597 Patients Enrolled for Asthma

University of Colorado, DenverLead Sponsor

1,752 Previous Clinical Trials

2,165,539 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

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