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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762395
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : March 3, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Obesity Drug: CXA-10 Drug: Matching Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 8, 2023
Estimated Primary Completion Date : November 30, 2028
Estimated Study Completion Date : January 30, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: CXA-10
6 weeks of treatment with 150 mg/day of orally administered CXA-10
Other Name: 10-nitro-9(E)-octadec-9-enoic acid
Placebo Comparator: 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.
 Drug: Matching Placebo
6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Methacholine challenge dose per spirometry [ Time Frame: Through study completion, up to 18 weeks ]
    To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose

  2. Changes in pre-bronchodilator FEV1 per spirometry [ Time Frame: Through study completion, up to 18 weeks ]
    To determine the efficacy of CXA-10 by improving FEV1


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762395


Contacts
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Contact: Asthma Research 1 (844) 365-0852 asthmaresearch@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Asthma Research    844-365-0852      
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Fernando Holguin, MD, MPH University of Colorado Denver- Anschutz Medical Campus
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03762395    
Other Study ID Numbers: 19-0510; 21-3959
5R01HL132550-03 ( U.S. NIH Grant/Contract )
1R61HL157069-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
CXA-10
Anti-Inflammatory Agents