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Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma (ALMA; LIMA)

Primary Purpose

Asthma, Obesity

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CXA-10

Matching Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
BMI >/= 30
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
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:

Respiratory tract infection within the last 4 weeks
Oral or systemic corticosteroid burst within the last 4 weeks
Asthma-related hospitalization within the last 6 weeks
Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
Asthma-related ER visit within the previous 4 weeks
Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years

Sites / Locations

University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CXA-10

Matching Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Changes in pre-bronchodilator FEV1 per spirometry

To determine the efficacy of CXA-10 by improving FEV1

Secondary Outcome Measures

Full Information

NCT ID

NCT03762395

First Posted

August 1, 2018

Last Updated

March 1, 2023

Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03762395

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2023 (Actual)

Primary Completion Date

November 30, 2028 (Anticipated)

Study Completion Date

January 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CXA-10

Arm Type

Experimental

Arm Description

Arm Title

Matching Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

CXA-10

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Methacholine challenge dose per spirometry

Description

To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose

Time Frame

Through study completion, up to 18 weeks

Title

Changes in pre-bronchodilator FEV1 per spirometry

Description

To determine the efficacy of CXA-10 by improving FEV1

Time Frame

Through study completion, up to 18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. BMI >/= 30 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 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: Respiratory tract infection within the last 4 weeks Oral or systemic corticosteroid burst within the last 4 weeks Asthma-related hospitalization within the last 6 weeks Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma Asthma-related ER visit within the previous 4 weeks Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Asthma Research

Phone

1 (844) 365-0852

asthmaresearch@ucdenver.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Holguin, MD, MPH

Organizational Affiliation

University of Colorado Denver- Anschutz Medical Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asthma Research

Phone

844-365-0852

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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