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MitoQ for the Treatment of Metabolic Dysfunction in Asthma (MIMDA)

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: NCT04026711
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : January 24, 2022
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Anne Dixon, University of Vermont

Brief Summary:

A 14-week, randomized, placebo-controlled, double-masked clinical trial in 40 obese patients with poorly controlled asthma.

The intervention is Mitoquinol (MitoQ) versus placebo.

The primary aim of this pilot study is to determine if MitoQ improves airway reactivity in obese patients with asthma.


Condition or disease Intervention/treatment Phase
Asthma Obesity Drug: Mitoquinol Drug: Placebo oral tablet Phase 1

Detailed Description:

Study aim:

The objective of this proposal is to conduct a pilot clinical trial to determine if the mitochondrial-targeted anti-oxidant MitoQ improves airway reactivity in obese patients with poorly controlled asthma.

Type of Study:

A 14 weeks, prospective, two center (Duke and the University of Vermont), randomized, placebo-controlled, double-masked clinical trial.

Study Population:

40 patients with obesity and poorly controlled asthma.

Intervention:

MitoQ 40 mg per day versus placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double masked study
Primary Purpose: Treatment
Official Title: MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: MitoQ
MitoQ 40 mg per day for 12 weeks
Drug: Mitoquinol
Mitoquinol (MitoQ) 40 mg per day for 12 weeks
Other Name: MitoQ

Placebo Comparator: Placebo
placebo daily for 12 weeks
Drug: Placebo oral tablet
Placebo daily for 12 weeks




Primary Outcome Measures :
  1. change in airway reactivity [ Time Frame: Through study completion, 12 weeks ]
    airway reactivity to methacholine


Secondary Outcome Measures :
  1. Change in 8-isoprostanes. [ Time Frame: Through study completion, 12 weeks ]
    serum, sputum and nasal lavage 8-isoprostanes

  2. sputum cell counts. [ Time Frame: Through study completion, 12 weeks ]
    change induced sputum cell counts

  3. Asthma Control Test (ACT) [ Time Frame: Through study completion, 12 weeks ]
    To collect data on asthma symptoms measured by asthma control questionnaire determined by a score from 5-25 (the lower the score, the worse the asthma symptoms)

  4. Adherence [ Time Frame: Through study completion, 12 weeks ]
    pill counts

  5. Asthma quality of life questionnaire. [ Time Frame: Through study completion, 12 weeks ]
    The Marks Asthma Quality of Life Questionnaire (Marks AQLQ). Minimum score of 20, maximum score of 100. The greater the score, the more asthma is affecting quality of life. Minimum score is 5, maximum score is 35. The greater the score, the more severe the asthma symptoms.

  6. Asthma Symptom Utility Index [ Time Frame: Through study completion, 12 weeks ]
    The Asthma Symptom Utility Index (ASUI), a 2-week utility-weighted asthma symptom questionnaire. Used to collect data on frequency and severity of asthma symptoms.

  7. Lung function FEV1 [ Time Frame: Through study completion, 12 weeks ]
    FEV1

  8. Lung function, FVC [ Time Frame: Through study completion, 12 weeks ]
    FVC

  9. change in lung impedance [ Time Frame: Through study completion, 12 weeks ]
    measured by forced oscillation

  10. Adverse effects [ Time Frame: Through study completion, 12 weeks ]
    assessed at each study visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. participant reported physician diagnosis of asthma
  2. participant reported on regular prescribed controller therapy for at least 3 months
  3. positive methacholine challenge (as determined by spirometry PD20 or oscillometry PD50 ≤ 4.0 mg/ml at visit 2)
  4. age: ≥18 years
  5. BMI ≥ 30 kg/m2 (at visit 1)
  6. poorly controlled asthma defined as one of the following:

    1. Asthma Control Test5 Score ≤ 19 (at visit 1), or
    2. Participant reported use of rescue inhaler on average > 2 uses/week for preceding month, or
    3. Participant reported nocturnal asthma awakening on average 1 or more times / week in preceding month, or
    4. Participant reported ED/hospital visit or prednisone course for asthma in past six months
  7. ability and willingness to provide informed consent

Exclusion criteria:

  1. participant reported use of an investigational agent in the prior 30 days
  2. participant reported physician diagnosis of chronic obstructive pulmonary disease
  3. pregnancy and/or participant reported lactation
  4. females of childbearing age who do not agree to practice an adequate birth control method for the duration of the study (abstinence, combination barrier and spermicide, or hormonal)
  5. participant reported greater than 10 pack year smoking history
  6. participant reported smoking conventional tobacco products (cigar, cigarette, & pipes) within the last 6 months
  7. participant reported e-cigarette use more than 2x/week
  8. participant unwilling to withhold e-cigarette use for the duration of the study
  9. participant reported vaping more than 2x/week
  10. participant unwilling to withhold vaping for the duration of the study
  11. participant reported marijuana use (inhalation) more than 2x/week
  12. participant unwilling to withhold marijuana use (inhalation) for the duration of the study
  13. participant reported sinus surgery performed ≤ 4 weeks from visit 1
  14. participant reported eye surgery within the prior 3 months
  15. participant reported use of the antioxidants idebenone or co-enzyme Q10 within 8 weeks
  16. participant reported tendency to develop severe nose bleeds
  17. FEV1 ˂ 60% predicted or < 1.5 Liters at visit 1
  18. participant reported treatment for asthma exacerbation in the previous 4 weeks
  19. participant was not able to complete at least 50% of the days on the diary cards returned at visit 2
  20. other significant disease that in the opinion of the investigator would interfere with the study

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): NCT04026711


Contacts
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Contact: Olivia Johnson, MS, RDN 802-847-2160 olivia.johnson@uvmhealth.org

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Catherine Foss, BS, RRT, RPFT, CCRC    919-479-0861    catherine.foss@duke.edu   
Sub-Investigator: Loretta Que, MD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Olivia Johnson, MS, RDN    802-847-2160    olivia.johnson@uvmhealth.org   
Principal Investigator: Anne E Dixon, MD         
Sponsors and Collaborators
University of Vermont
Duke University
Investigators
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Principal Investigator: Anne E Dixon, MD University of Vermont
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Responsible Party: Anne Dixon, Professor of Medicine, Director of Pulmonary and Critical Care Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT04026711    
Other Study ID Numbers: 18-0564
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
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