NCT04026711: MIMDA

MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Completed Phase 1 Results posted Last updated 11 December 2025

What this trial tests

Phase 1 trial testing Mitoquinol in Asthma in 47 participants. Completed in 31 March 2024.

Timeline

1 January 2020

Primary endpoint
31 March 2024

31 March 2024

Quick facts

Lead sponsor	University of Vermont
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	47
Start date	1 January 2020
Primary completion	31 March 2024
Estimated completion	31 March 2024
Sites	2 locations across United States

Drugs / interventions tested

• Mitoquinol — full drug profile →
• Placebo oral tablet — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →
• Obesity — all drugs for Obesity →

Sponsor

University of Vermont

Who can join

18 and older, any sex, with Asthma or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Airway Reactivity Primary · Through study completion, 12 weeks

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

Group	Value	95% CI
MitoQ	0	-25.5 – 1.4
Placebo	-0.8	-57 – 0

Change in Asthma Control Test (ACT) Secondary · Through study completion, 12 weeks

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)

Group	Value	95% CI
MitoQ	1	-1 – 2
Placebo	1	-2 – 2

Number of Participants With Adherence at 12 Weeks Secondary · Through study completion, 12 weeks

Adherence determined from pill counts (classified as adherent if used at least 80% of predicted pills)

Group	Value	95% CI
MitoQ	15
Placebo	12

Change in Asthma Quality of Life Questionnaire Score Secondary · Through study completion, 12 weeks

The Marks Asthma Quality of Life Questionnaire (Marks AQLQ). units on a scale from 1 to 5. Higher score indicates better quality of life

Group	Value	95% CI
MitoQ	-0.08	-0.35 – 0.10
Placebo	-0.05	-0.30 – 0.15

Change in FEV1 Secondary · Through study completion, 12 weeks

Change in forced expiratory volume in one second between baseline and 12 week visit

Group	Value	95% CI
MitoQ	-0.01	0.18 – 0.24
Placebo	0.03	-0.13 – 0.14

Change in FVC Secondary · Through study completion, 12 weeks

Change in forced vital capacity from baseline to 12 weeks measured in liters

Group	Value	95% CI
MitoQ	-0.01	-0.19 – 0.02
Placebo	0.01	-0.18 – 0.22

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until study end (after 12 weeks on study drug). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MitoQ

Serious: 0/20 (0%)

Deaths: 0/20

Placebo

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (10 terms — click to expand)

Reaction	System	MitoQ	Placebo
headache	General disorders	—	—
gastroesophageal reflux/ nausea	Gastrointestinal disorders	—	—
muscle pain	Musculoskeletal and connective tissue disorders	—	—
joint pain	Musculoskeletal and connective tissue disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—	—
skin rash	Skin and subcutaneous tissue disorders	—	—
abdominal pain	Gastrointestinal disorders	—	—
fatigue	General disorders	—	—
dizziness	General disorders	—	—

Data from ClinicalTrials.gov NCT04026711 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondria-Targeted Antioxidants as a Therapeutic Strategy for Chronic Obstructive Pulmonary Disease.
   Fairley LH, Das S, Dharwal V, Amorim N, et al · · 2023 · cited 29× · PMID 37107348 · DOI 10.3390/antiox12040973
2. Multifaceted functions of Drp1 in hypoxia/ischemia-induced mitochondrial quality imbalance: from regulatory mechanism to targeted therapeutic strategy.
   Hao S, Huang H, Ma RY, Zeng X, et al · · 2023 · cited 28× · PMID 37833768 · DOI 10.1186/s40779-023-00482-8
3. Obesity-related Asthma: A Pathobiology-based Overview of Existing and Emerging Treatment Approaches.
   Althoff MD, Gaietto K, Holguin F, Forno E. · · 2024 · cited 15× · PMID 39311907 · DOI 10.1164/rccm.202406-1166so
4. Cytotoxicity and Mitochondrial Effects of Phenolic and Quinone-Based Mitochondria-Targeted and Untargeted Antioxidants on Human Neuronal and Hepatic Cell Lines: A Comparative Analysis.
   Fernandes C, Videira AJC, Veloso CD, Benfeito S, et al · · 2021 · cited 12× · PMID 34827603 · DOI 10.3390/biom11111605
5. Mitochondrial Dysfunction and Metabolic Reprogramming in Obesity and Asthma.
   Hartsoe P, Holguin F, Chu HW. · · 2024 · cited 11× · PMID 38474191 · DOI 10.3390/ijms25052944
6. Effects of Oxidative Stress on Airway Epithelium Permeability in Asthma and Potential Implications for Patients with Comorbid Obesity.
   Kim HR, Ingram JL, Que LG. · · 2023 · cited 11× · PMID 37181453 · DOI 10.2147/jaa.s402340
7. Weight Loss Interventions for Adults With Obesity-Related Asthma.
   Foer D, Forno E, Holguin F, Cahill KN. · · 2024 · cited 7× · PMID 38159807 · DOI 10.1016/j.jaip.2023.12.041
8. Precision Medicine: Therapeutically Targeting Mitochondrial Alterations in Heart Failure.
   Parker AM, Lees JG, Murray AJ, Velagic A, et al · · 2025 · cited 5× · PMID 40845481 · DOI 10.1016/j.jacbts.2025.101345