Status:
COMPLETED
MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Duke University
Conditions:
Asthma
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04026711
Start Date
January 1 2020
End Date
March 31 2024
Last Update
December 11 2025
Active Locations (2)
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1
Duke University
Durham, North Carolina, United States, 27710
2
University of Vermont
Burlington, Vermont, United States, 05405