Clinical trial NCT04026711: MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Official title: MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Obesity
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2019-07-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 this pilot study is to determine if MitoQ improves airway reactivity in obese patients with asthma.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in airway reactivity
timeFrame: Through study completion, 12 weeks
Secondary outcomes:
measure: Change in 8-isoprostanes.
timeFrame: Through study completion, 12 weeks
measure: sputum cell counts.
timeFrame: Through study completion, 12 weeks
measure: Asthma Control Test (ACT)
timeFrame: Through study completion, 12 weeks
measure: Adherence
timeFrame: Through study completion, 12 weeks
measure: Asthma quality of life questionnaire.
timeFrame: Through study completion, 12 weeks
measure: Asthma Symptom Utility Index
timeFrame: Through study completion, 12 weeks
measure: Lung function FEV1
timeFrame: Through study completion, 12 weeks
measure: Lung function, FVC
timeFrame: Through study completion, 12 weeks
measure: change in lung impedance
timeFrame: Through study completion, 12 weeks
measure: Adverse effects
timeFrame: Through study completion, 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Anne E Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References: