MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Change in Airway Reactivity
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double masked study
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MitoQ
MitoQ 40 mg per day for 12 weeks
Intervention: Mitoquinol (Drug)
Placebo
placebo daily for 12 weeks
Intervention: Placebo oral tablet (Drug)
Outcomes
Primary Outcomes
Change in Airway Reactivity
Time Frame: Through study completion, 12 weeks
change in airway reactivity, measured by change in the concentration of methacholine producing a 20 % decrease in forced expiratory volume in one second, from baseline
Secondary Outcomes
- Change in FVC(Through study completion, 12 weeks)
- Change in Asthma Control Test (ACT)(Through study completion, 12 weeks)
- Number of Participants With Adherence at 12 Weeks(Through study completion, 12 weeks)
- Change in FEV1(Through study completion, 12 weeks)
- Change in Asthma Quality of Life Questionnaire Score(Through study completion, 12 weeks)
Investigators
Anne Dixon
Professor of Medicine, Director of Pulmonary and Critical Care Medicine
University of Vermont