AsthmaPhase 1MIMDANCT04026711

MitoQ for the Treatment of Metabolic Dysfunction in Asthma

A Phase 1 study testing Mitoquinol in people with Asthma and Obesity, run by University of Vermont at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma, Obesity
What is being tested?: Mitoquinol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 2 sitesUnited States
Study dates: 1 Jan 2020to 31 Mar 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 11Show fewer

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Vermont
Burlington, Vermont, 05405
Duke University
Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the 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.

Conditions: Asthma, Obesity
Being tested: Mitoquinol, Placebo oral tablet
Medical subject headings: Asthma, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MitoquinolDrug
Also called MitoQ
Mitoquinol (MitoQ) 40 mg per day for 12 weeks
Placebo oral tabletDrug
Placebo daily for 12 weeks

Study groups in NCT04026711
Study group	Role	What they receive
MitoQ	Active comparator	MitoQ 40 mg per day for 12 weeks Receives: Drug: Mitoquinol
Placebo	Placebo comparator	placebo daily for 12 weeks Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Through study completion, 12 weeks

Secondary outcomes (5)

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)
Measured: 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)
Measured: 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
Measured: Through study completion, 12 weeks
Change in FEV1
Change in forced expiratory volume in one second between baseline and 12 week visit
Measured: Through study completion, 12 weeks
Change in FVC
Change in forced vital capacity from baseline to 12 weeks measured in liters
Measured: Through study completion, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202031 Mar 2024

First posted19 Jul 2019
Study start1 Jan 2020
Primary completion31 Mar 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04026711
Sponsor's protocol ID: 18-0564
Acronym: MIMDA
Status last verified: Nov 2025
First submitted: 30 May 2019
Last updated: 11 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MitoQ for the Treatment of Metabolic Dysfunction in Asthma
ClinicalTrials.gov ID: NCT04026711
Acronym / sponsor ID: MIMDA / 18-0564
Conditions: Asthma, Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: University of VermontUniversity, hospital or other
Collaborators: Duke University
Study start: 1 Jan 2020 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 19 Jul 2019 (actual)
Results: Posted 11 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study aim:

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MitoQ	Active comparator	Drug: MitoquinolMitoQ 40 mg per day for 12 weeks
Placebo	Placebo comparator	Drug: Placebo oral tabletplacebo daily for 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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)

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MitoquinolAlso: MitoQMitoquinol (MitoQ) 40 mg per day for 12 weeks	Drug	MitoQ
Placebo oral tabletPlacebo daily for 12 weeks	Drug	Placebo

Primary outcome

Change in Airway Reactivity
Time frame: 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

5 secondary outcomes

Change in Asthma Control Test (ACT)
Time frame: Through study completion, 12 weeks
Number of Participants With Adherence at 12 Weeks
Time frame: Through study completion, 12 weeks
Change in Asthma Quality of Life Questionnaire Score
Time frame: Through study completion, 12 weeks
Change in FEV1
Time frame: Through study completion, 12 weeks
Change in FVC
Time frame: Through study completion, 12 weeks

Results and safety

Results posted to the registry on 11 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MitoQ	20	18
Placebo	18	18

Primary outcome: Change in Airway Reactivity

Time frame: Through study completion, 12 weeks. Median (Inter-Quartile Range). Unit: μg methacholine

Measure	MitoQ n = 18	Placebo n = 14
Value	0 (-25.5 to 1.4)	-0.8 (-57 to 0)

MitoQ vs Placebo: p = 0.81, Wilcoxon rank sum

Population analysed: 2 participants in the MitoQ group withdrew 4 participants in the placebo group did not perform methacholine at 12 week visit: Lung function too low (FEV1 less than 60%), and participants unable to complete testing

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until study end (after 12 weeks on study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MitoQ	0 of 20 (0%)	12 of 20 (60%)	0 of 20
Placebo	0 of 18 (0%)	10 of 18 (55.6%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne E Dixon, MD principal investigator

University of Vermont

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mitoquinol in people with Asthma and Obesity, run by University of Vermont at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Airway Reactivity (time frame: Through study completion, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026711.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.