NCT04026711CompletedPhase 1
MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 30 May 2019
- Start date
- Jan 2020
- Primary completion date
- Mar 2024
- Lead sponsor
- University of Vermont
- NCT number
- NCT04026711
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 47
- From Jan 2020 to the primary completion date, Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participant reported use of an investigational agent in the prior 30 days
- participant reported sinus surgery performed ≤ 4 weeks from visit 1
- participant reported eye surgery within the prior 3 months
- participant reported treatment for asthma exacerbation in the previous 4 weeks
Other illness
- participant reported physician diagnosis of chronic obstructive pulmonary disease
- other significant disease that in the opinion of the investigator would interfere with the study
Age
- 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)
Other
- pregnancy and/or participant reported lactation
- 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 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 was not able to complete at least 50% of the days on the diary cards returned at visit 2
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.