MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Conditions
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Asthma, Obesity

Intervention / Treatment
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* Drug: Mitoquinol
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MitoQ<br>MitoQ 40 mg per day for 12 weeks | Drug: Mitoquinol<br>* Mitoquinol (MitoQ) 40 mg per day for 12 weeks<br>* Other names: MitoQ;|
| Placebo Comparator: Placebo<br>placebo daily for 12 weeks | Drug: Placebo oral tablet<br>* Placebo daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in airway reactivity | airway reactivity to methacholine | Through study completion, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 8-isoprostanes. | serum, sputum and nasal lavage 8-isoprostanes | Through study completion, 12 weeks | 
| sputum cell counts. | change induced sputum cell counts | Through study completion, 12 weeks | 
| Asthma Control Test (ACT) | To collect data on asthma symptoms measured by asthma control questionnaire determined by a score from 5-25 (the lower the score, the worse the asthma symptoms) | Through study completion, 12 weeks | 
| Adherence | pill counts | Through study completion, 12 weeks | 
| Asthma quality of life questionnaire. | The Marks Asthma Quality of Life Questionnaire (Marks AQLQ). Minimum score of 20, maximum score of 100. The greater the score, the more asthma is affecting quality of life. Minimum score is 5, maximum score is 35. The greater the score, the more severe the asthma symptoms. | Through study completion, 12 weeks | 
| Asthma Symptom Utility Index | The Asthma Symptom Utility Index (ASUI), a 2-week utility-weighted asthma symptom questionnaire. Used to collect data on frequency and severity of asthma symptoms. | Through study completion, 12 weeks | 
| Lung function FEV1 | FEV1 | Through study completion, 12 weeks | 
| Lung function, FVC | FVC | Through study completion, 12 weeks | 
| change in lung impedance | measured by forced oscillation | Through study completion, 12 weeks | 
| Adverse effects | assessed at each study visit | Through study completion, 12 weeks |