MitoQ for the Treatment of Metabolic Dysfunction in Asthma

NCT ID: NCT04026711

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-03-31

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.

Conditions

Asthma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MitoQ

MitoQ 40 mg per day for 12 weeks

Group Type: ACTIVE_COMPARATOR

Mitoquinol

Intervention Type: DRUG

Mitoquinol (MitoQ) 40 mg per day for 12 weeks

Placebo

placebo daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo daily for 12 weeks

Interventions

Mitoquinol

Mitoquinol (MitoQ) 40 mg per day for 12 weeks

Intervention Type: DRUG

Placebo oral tablet

Placebo daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

MitoQ

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Anne Dixon

Professor of Medicine, Director of Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne E Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Duke University

Durham, North Carolina, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-0564

Identifier Type: -

Identifier Source: org_study_id