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Anti Inflammatory Lipid Mediators in Asthma (ALMA)

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ClinicalTrials.gov Identifier: NCT03762395
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : March 27, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

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

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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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CXA-10
Administered orally, continuously, and daily for at least12 weeks. Dispensed at Visits 1, 2, 3 (if needed). Washout period of at least 4 weeks and then enter crossover phase of an additional 12 weeks. Drug will be dispensed at Visits 4 and 5.
Drug: CXA-10
12 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 12 weeks. Dispensed at Visits 1, 2, 3 (if needed). Washout period of at least 4 weeks and then enter crossover phase of an additional 12 weeks. Placebo will be dispensed at visits 4 and 5.
Drug: Matching Placebo
12 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)




Primary Outcome Measures :
  1. Change in Methacholine challenge dose per spirometry [ Time Frame: Through study completion, up to 36 weeks ]
    To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose



Information from the National Library of Medicine

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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

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

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

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03762395     History of Changes
Other Study ID Numbers: 17-0233
5R01HL132550-03 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
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
Anti-Inflammatory Agents