Phase 1 N=38 Randomized Double-blind Treatment

MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Asthma · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT04026711 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Change in Airway Reactivity — 0; -0.8 μg methacholine — p=0.81

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Mitoquinol (Drug); Placebo oral tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Vermont
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Airway Reactivity	0; -0.8	0.81
SECONDARY Change in Asthma Control Test (ACT)	1; 1	—
SECONDARY Number of Participants With Adherence at 12 Weeks	15; 12	—
SECONDARY Change in Asthma Quality of Life Questionnaire Score	-0.08; -0.05	—
SECONDARY Change in FEV1	-0.01; 0.03	—
SECONDARY Change in FVC	-0.01; 0.01	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04026711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.