MitoQ for the Treatment of Metabolic Dysfunction in 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.

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