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

Primary Purpose

Asthma, Obesity

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mitoquinol
Placebo oral tablet
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

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

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

Sites / Locations

  • Duke UniversityRecruiting
  • University of VermontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MitoQ

Placebo

Arm Description

MitoQ 40 mg per day for 12 weeks

placebo daily for 12 weeks

Outcomes

Primary Outcome Measures

change in airway reactivity
airway reactivity to methacholine

Secondary Outcome Measures

Change in 8-isoprostanes.
serum, sputum and nasal lavage 8-isoprostanes
sputum cell counts.
change induced sputum cell counts
Asthma Control Test (ACT)
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)
Adherence
pill counts
Asthma quality of life questionnaire.
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.
Asthma Symptom Utility Index
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.
Lung function FEV1
FEV1
Lung function, FVC
FVC
change in lung impedance
measured by forced oscillation
Adverse effects
assessed at each study visit

Full Information

First Posted
May 30, 2019
Last Updated
January 26, 2023
Sponsor
University of Vermont
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04026711
Brief Title
MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Acronym
MIMDA
Official Title
MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double masked study
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitoQ
Arm Type
Active Comparator
Arm Description
MitoQ 40 mg per day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Mitoquinol
Other Intervention Name(s)
MitoQ
Intervention Description
Mitoquinol (MitoQ) 40 mg per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo daily for 12 weeks
Primary Outcome Measure Information:
Title
change in airway reactivity
Description
airway reactivity to methacholine
Time Frame
Through study completion, 12 weeks
Secondary Outcome Measure Information:
Title
Change in 8-isoprostanes.
Description
serum, sputum and nasal lavage 8-isoprostanes
Time Frame
Through study completion, 12 weeks
Title
sputum cell counts.
Description
change induced sputum cell counts
Time Frame
Through study completion, 12 weeks
Title
Asthma Control Test (ACT)
Description
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)
Time Frame
Through study completion, 12 weeks
Title
Adherence
Description
pill counts
Time Frame
Through study completion, 12 weeks
Title
Asthma quality of life questionnaire.
Description
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.
Time Frame
Through study completion, 12 weeks
Title
Asthma Symptom Utility Index
Description
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.
Time Frame
Through study completion, 12 weeks
Title
Lung function FEV1
Description
FEV1
Time Frame
Through study completion, 12 weeks
Title
Lung function, FVC
Description
FVC
Time Frame
Through study completion, 12 weeks
Title
change in lung impedance
Description
measured by forced oscillation
Time Frame
Through study completion, 12 weeks
Title
Adverse effects
Description
assessed at each study visit
Time Frame
Through study completion, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: participant reported physician diagnosis of asthma participant reported on regular prescribed controller therapy for at least 3 months positive methacholine challenge (as determined by spirometry PD20 or oscillometry PD50 ≤ 4.0 mg/ml at visit 2) age: ≥18 years BMI ≥ 30 kg/m2 (at visit 1) poorly controlled asthma defined as one of the following: Asthma Control Test5 Score ≤ 19 (at visit 1), or Participant reported use of rescue inhaler on average > 2 uses/week for preceding month, or Participant reported nocturnal asthma awakening on average 1 or more times / week in preceding month, or Participant reported ED/hospital visit or prednisone course for asthma in past six months ability and willingness to provide informed consent Exclusion criteria: participant reported use of an investigational agent in the prior 30 days participant reported physician diagnosis of chronic obstructive pulmonary disease pregnancy and/or participant reported lactation 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) participant reported greater than 10 pack year smoking history participant reported smoking conventional tobacco products (cigar, cigarette, & pipes) within the last 6 months participant reported e-cigarette use more than 2x/week participant unwilling to withhold e-cigarette use for the duration of the study participant reported vaping more than 2x/week participant unwilling to withhold vaping for the duration of the study participant reported marijuana use (inhalation) more than 2x/week participant unwilling to withhold marijuana use (inhalation) for the duration of the study participant reported sinus surgery performed ≤ 4 weeks from visit 1 participant reported eye surgery within the prior 3 months participant reported use of the antioxidants idebenone or co-enzyme Q10 within 8 weeks participant reported tendency to develop severe nose bleeds FEV1 ˂ 60% predicted or < 1.5 Liters at visit 1 participant reported treatment for asthma exacerbation in the previous 4 weeks participant was not able to complete at least 50% of the days on the diary cards returned at visit 2 other significant disease that in the opinion of the investigator would interfere with the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Johnson, MS, RDN
Phone
802-847-2160
Email
olivia.johnson@uvmhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne E Dixon, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Foss, BS, RRT, RPFT, CCRC
Phone
919-479-0861
Email
catherine.foss@duke.edu
First Name & Middle Initial & Last Name & Degree
Loretta Que, MD
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Johnson, MS, RDN
Phone
802-847-2160
Email
olivia.johnson@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Anne E Dixon, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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MitoQ for the Treatment of Metabolic Dysfunction in Asthma

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