MitoQ for the Treatment of Metabolic Dysfunction in Asthma

University of Vermont47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma Obesity

Interventions

MitoquinolDRUG

Mitoquinol (MitoQ) 40 mg per day for 12 weeks

Placebo oral tabletDRUG

Placebo daily for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. participant reported physician diagnosis of asthma 2. participant reported on regular prescribed controller therapy for at least 3 months 3. positive methacholine challenge (as determined by spirometry PD20 or oscillometry PD50 ≤ 4.0 mg/ml at visit 2) 4. age: ≥18 years 5. BMI ≥ 30 kg/m2 (at visit 1) 6. poorly controlled asthma defined as one of the following: 1. Asthma Control Test5 Score ≤ 19 (at visit 1), or 2. Participant reported use of rescue inhaler on average \> 2 uses/week for preceding month, or 3. Participant reported nocturnal asthma awakening on average 1 or more times / week in preceding month, or 4. Participant reported ED/hospital visit or prednisone course for asthma in past six months 7. ability and willingness to provide informed consent Exclusion criteria: 1. participant reported use of an investigational agent in the prior 30 days 2. participant reported physician diagnosis of chronic obstructive pulmonary disease 3. pregnancy and/or participant reported lactation 4. 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) 5. participant reported greater than 10 pack year smoking history 6. participant reported smoking conventional tobacco products (cigar, cigarette, \& pipes) within the last 6 months 7. participant reported e-cigarette use more than 2x/week 8. participant unwilling to withhold e-cigarette use for the duration of the study 9. participant reported vaping more than 2x/week 10. participant unwilling to withhold vaping for the duration of the study 11. participant reported marijuana use (inhalation) more than 2x/week 12. participant unwilling to withhold marijuana use (inhalation) for the duration of the study 13. participant reported sinus surgery performed ≤ 4 weeks from visit 1 14. participant reported eye surgery within the prior 3 months 15. participant reported use of the antioxidants idebenone or co-enzyme Q10 within 8 weeks 16. participant reported tendency to develop severe nose bleeds 17. FEV1 ˂ 60% predicted or \< 1.5 Liters at visit 1 18. participant reported treatment for asthma exacerbation in the previous 4 weeks 19. participant was not able to complete at least 50% of the days on the diary cards returned at visit 2 20. other significant disease that in the opinion of the investigator would interfere with the study

Locations (2)

Duke University

Durham, North Carolina, United States

University of Vermont

Burlington, Vermont, United States

Outcomes

Primary Outcomes

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