MitoQ for the Treatment of Metabolic Dysfunction in Asthma

Phase 1

Completed

• Conditions: Asthma; Obesity
• Interventions: Drug: Mitoquinol; Drug: Placebo oral tablet

• Registration Number: NCT04026711
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2020-01-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MitoQ	Mitoquinol	MitoQ 40 mg per day for 12 weeks
Placebo	Placebo oral tablet	placebo daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
change in airway reactivity	Through study completion, 12 weeks	airway reactivity to methacholine

Secondary Outcome Measures

Name	Time	Method
Change in 8-isoprostanes.	Through study completion, 12 weeks	serum, sputum and nasal lavage 8-isoprostanes
sputum cell counts.	Through study completion, 12 weeks	change induced sputum cell counts
Asthma Control Test (ACT)	Through study completion, 12 weeks	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)
Adherence	Through study completion, 12 weeks	pill counts
Lung function, FVC	Through study completion, 12 weeks	FVC
change in lung impedance	Through study completion, 12 weeks	measured by forced oscillation
Adverse effects	Through study completion, 12 weeks	assessed at each study visit
Asthma quality of life questionnaire.	Through study completion, 12 weeks	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.
Asthma Symptom Utility Index	Through study completion, 12 weeks	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.
Lung function FEV1	Through study completion, 12 weeks	FEV1

Trial Locations

Locations (2)

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Duke University; 🇺🇸 Durham, North Carolina, United States