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Mitochondrial Targeted Antioxidant
MitoQ for Asthma (MIMDA Trial)
Phase 1
Waitlist Available
Led By Anne E Dixon, MD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Poorly controlled asthma defined as one of the following: Asthma Control Test5 Score ≤ 19 (at visit 1), or Participant reported use of rescue inhaler on average > 2 uses/week for preceding month, or Participant reported nocturnal asthma awakening on average 1 or more times / week in preceding month, or Participant reported ED/hospital visit or prednisone course for asthma in past six months
Participant reported physician diagnosis of asthma
Must not have
Participant reported physician diagnosis of chronic obstructive pulmonary disease
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 12 weeks
Summary
This trial will test whether the supplement Mitoquinol can help improve asthma symptoms in obese patients.
Who is the study for?
This trial is for obese adults with poorly controlled asthma, diagnosed by a physician and on regular therapy. They must have reactive airways as shown by tests, use their rescue inhaler frequently or have had recent severe symptoms or treatment. Smokers, pregnant women, those using certain drugs or with other significant diseases are excluded.
What is being tested?
The study compares Mitoquinol (MitoQ), an antioxidant supplement, to a placebo over 14 weeks to see if it improves lung function in obese patients with asthma. It's randomized and double-masked so neither the participants nor researchers know who gets what until the end.
What are the potential side effects?
While specific side effects of MitoQ aren't listed here, antioxidants like MitoQ can sometimes cause digestive discomfort, allergic reactions, or headaches. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My asthma is not well-controlled, based on symptoms or recent emergency care.
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I have been diagnosed with asthma by a doctor.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with COPD by a doctor.
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I agree to use effective birth control during the study.
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I often have severe nosebleeds.
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I have been treated for an asthma attack in the last 4 weeks.
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I have smoked more than 10 packs of cigarettes a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in airway reactivity
Secondary study objectives
Adherence
Adverse effects
Asthma Control Test (ACT)
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: MitoQActive Control1 Intervention
MitoQ 40 mg per day for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
placebo daily for 12 weeks
Find a Location
Who is running the clinical trial?
University of VermontLead Sponsor
277 Previous Clinical Trials
3,744,067 Total Patients Enrolled
10 Trials studying Asthma
4,767 Patients Enrolled for Asthma
Duke UniversityOTHER
2,452 Previous Clinical Trials
2,971,729 Total Patients Enrolled
21 Trials studying Asthma
55,212 Patients Enrolled for Asthma
Anne E Dixon, MDPrincipal InvestigatorUniversity of Vermont
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Asthma
28 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had sinus surgery less than 4 weeks ago.My asthma is not well-controlled, based on symptoms or recent emergency care.I have been diagnosed with COPD by a doctor.I have been on prescribed asthma control medication for over 3 months.Your lung function is below a certain level.You have smoked cigarettes, cigars, or pipes in the past 6 months.I agree to use effective birth control during the study.I often have severe nosebleeds.You use a vaping device more than twice a week.I had eye surgery in the last 3 months.You have a positive test for methacholine challenge, which means your airways are more reactive than normal.You use e-cigarettes more than twice a week.I have been treated for an asthma attack in the last 4 weeks.I have smoked more than 10 packs of cigarettes a year.I have used idebenone or co-enzyme Q10 in the last 8 weeks.I have been diagnosed with asthma by a doctor.You use marijuana by smoking it more than twice a week.You have a body mass index (BMI) of 30 or higher.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: MitoQ
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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