← Back to Search

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
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 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

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,586 Total Patients Enrolled
278 Trials studying Asthma
112,961 Patients Enrolled for Asthma
National Institutes of Health (NIH)NIH
2,706 Previous Clinical Trials
7,507,853 Total Patients Enrolled
59 Trials studying Asthma
8,597 Patients Enrolled for Asthma
University of Colorado, DenverLead Sponsor
1,743 Previous Clinical Trials
2,163,305 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can elderly citizens participate in this clinical trial?

"The age range for participants in this study is 18 to 65 years old."

Answered by AI

Is CXA-10 a new medication or has it been studied before?

"CXA-10 is being studied in 1 active clinical trial, with none of the investigations currently in Phase 3. Some of the research for CXA-10 is based in Aurora, Colorado; however, there is at least one other location where similar studies are taking place."

Answered by AI

Could I potentially enroll in this research program?

"60 individuals will be accepted into this trial that aim to study the effects of the medication on obesity. To qualify, participants must fall within the 18 to 65 age range and currently suffer from obesity."

Answered by AI

How many people are being asked to participate in this research?

"Presently, this study is not enrolling patients. The listing for this clinical trial was first posted on September 10th, 2019 and updated most recently on July 11th, 2022. However, if you are still seeking treatment options, there are 1,313 other trials actively recruiting patients with obesity and one CXA-10 trial currently looking for participants."

Answered by AI

Are people still being recruited for participation in this clinical trial?

"This research is not currently looking for more participants as it was last updated on 7/11/2022. The study, which began recruitment on 9/10/2019, has since finished. Although this trial is no longer active, there are 1,314 other trials that patients can consider enrolling in."

Answered by AI

Has CXA-10 undergone FDA approval for general use?

"CXA-10 falls into the Phase 2 category, meaning that while there is evidence suggesting it is safe, there is no data currently indicating that it is an effective treatment. Our analysts gave it a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Tried bupropion for obesity. While I did loss weight at first I ended up gaining it back after I discontinued the meds.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Can I join without having to travel to Denver?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma
2023. "Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03762395.
All > Pediatric Asthma > Asthma
~40 spots leftby Nov 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top