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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Asthma
• Intervention / Treatment: Drug: Mitoquinol; Drug: Placebo oral tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: MitoQ
Placebo Comparator: Placebo; placebo daily for 12 weeks	Drug: Placebo oral tablet; Placebo daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Airway Reactivity	change in airway reactivity, measured by change in the concentration of methacholine producing a 20 % decrease in forced expiratory volume in one second, from baseline	Through study completion, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Asthma Control Test (ACT)	To collect data on asthma symptoms measured by asthma control questionnaire with units on a scale from 5-25 (the lower the score, the worse the asthma symptoms)	Through study completion, 12 weeks
Number of Participants With Adherence at 12 Weeks	Adherence determined from pill counts (classified as adherent if used at least 80% of predicted pills)	Through study completion, 12 weeks
Change in Asthma Quality of Life Questionnaire Score	The Marks Asthma Quality of Life Questionnaire (Marks AQLQ). units on a scale from 1 to 5. Higher score indicates better quality of life	Through study completion, 12 weeks
Change in FEV1	Change in forced expiratory volume in one second between baseline and 12 week visit	Through study completion, 12 weeks
Change in FVC	Change in forced vital capacity from baseline to 12 weeks measured in liters	Through study completion, 12 weeks

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Duke University
• Investigators: Principal Investigator: Anne E Dixon, MD, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Asthma; mitoquinone; mitoquinol
• Other Study ID Numbers: 18-0564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No