MitoQ for the Treatment of Metabolic Dysfunction in Asthma

NCT04026711 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 18-0564
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Asthma Control Test (ACT)

  Through study completion, 12 weeks

• Number of Participants With Adherence at 12 Weeks

  Through study completion, 12 weeks

• Change in Asthma Quality of Life Questionnaire Score

  Through study completion, 12 weeks

• Change in FEV1

  Through study completion, 12 weeks

• Change in FVC

  Through study completion, 12 weeks

Study Arms (2)

MitoQ

ACTIVE COMPARATOR

MitoQ 40 mg per day for 12 weeks

Drug: Mitoquinol

Placebo

PLACEBO COMPARATOR

placebo daily for 12 weeks

Drug: Placebo oral tablet

Interventions

Placebo oral tablet DRUG

Placebo daily for 12 weeks

Placebo

Mitoquinol DRUG

Mitoquinol (MitoQ) 40 mg per day for 12 weeks

Also known as: MitoQ

MitoQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Duke University: collaborator

Study Sites (2)

Duke University

Durham, North Carolina, 27710, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Asthma; Obesity

Interventions

mitoquinol; mitoquinone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne Dixon, Professor of Medicine
• Organization: University of Vermont

anne.dixon@uvmhealth.org

802 847 0000

Study Officials

• Anne E Dixon, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masked study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: July 19, 2019
• Study Start: January 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)