MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Obesity Clinical Trial

— MIMDA  

Official title:

MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026711
• Other study ID #: 18-0564
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2023
• Source: University of Vermont
• Contact: Olivia Johnson, MS, RDN
• Phone: 802-847-2160
• Email: olivia.johnson[@]uvmhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

Drug:
• Mitoquinol
Mitoquinol (MitoQ) 40 mg per day for 12 weeks
• Placebo oral tablet
Placebo daily for 12 weeks

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in airway reactivity	airway reactivity to methacholine	Through study completion, 12 weeks
Secondary	Change in 8-isoprostanes.	serum, sputum and nasal lavage 8-isoprostanes	Through study completion, 12 weeks
Secondary	sputum cell counts.	change induced sputum cell counts	Through study completion, 12 weeks
Secondary	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
Secondary	Adherence	pill counts	Through study completion, 12 weeks
Secondary	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
Secondary	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
Secondary	Lung function FEV1	FEV1	Through study completion, 12 weeks
Secondary	Lung function, FVC	FVC	Through study completion, 12 weeks
Secondary	change in lung impedance	measured by forced oscillation	Through study completion, 12 weeks
Secondary	Adverse effects	assessed at each study visit	Through study completion, 12 weeks