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: Recruiting
• 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 (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Olivia Johnson, MS, RDN; Phone Number: 802-847-2160; Email: olivia.johnson@uvmhealth.org

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Catherine Foss, BS, RRT, RPFT, CCRC; Phone Number: 919-479-0861; Email: catherine.foss@duke.edu
      • Sub-Investigator: Loretta Que, MD
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Recruiting
      • University of Vermont
      • Contact: Olivia Johnson, MS, RDN; Phone Number: 802-847-2160; Email: olivia.johnson@uvmhealth.org
      • Principal Investigator: Anne E Dixon, MD

Participation Criteria

Eligibility Criteria

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

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	airway reactivity to methacholine	Through study completion, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 8-isoprostanes.	serum, sputum and nasal lavage 8-isoprostanes	Through study completion, 12 weeks
sputum cell counts.	change induced sputum cell counts	Through study completion, 12 weeks
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)	Through study completion, 12 weeks
Adherence	pill counts	Through study completion, 12 weeks
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.	Through study completion, 12 weeks
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.	Through study completion, 12 weeks
Lung function FEV1	FEV1	Through study completion, 12 weeks
Lung function, FVC	FVC	Through study completion, 12 weeks
change in lung impedance	measured by forced oscillation	Through study completion, 12 weeks
Adverse effects	assessed at each study visit	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 (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 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 (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• 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