MitoQ for the Treatment of Metabolic Dysfunction in Asthma
MitoQ for the Treatment of Metabolic Dysfunction in Asthma
Sponsors
Source
University of Vermont
Oversight Info
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
Brief Summary
A 14-week, randomized, placebo-controlled, double-masked clinical trial in 38 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:
38 patients with obesity and poorly controlled asthma.
Intervention:
MitoQ 40 mg per day versus placebo.
Overall Status
Not yet recruiting
Start Date
2019-09-01
Completion Date
2023-06-30
Primary Completion Date
2022-12-30
Phase
Phase 1
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
change in airway reactivity |
Through study completion, 12 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Change in 8-isoprostanes. |
Through study completion, 12 weeks |
|
sputum cell counts. |
Through study completion, 12 weeks |
|
Asthma Control Test (ACT) |
Through study completion, 12 weeks |
|
Adherence |
Through study completion, 12 weeks |
|
Asthma quality of life questionnaire. |
Through study completion, 12 weeks |
|
Asthma Symptom Utility Index |
Through study completion, 12 weeks |
|
Lung function FEV1 |
Through study completion, 12 weeks |
|
Lung function, FVC |
Through study completion, 12 weeks |
|
change in lung impedance |
Through study completion, 12 weeks |
|
Adverse effects |
Through study completion, 12 weeks |
Enrollment
38
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Mitoquinol (MitoQ) 40 mg per day for 12 weeks
Arm Group Label
MitoQ
Other Name
MitoQ
Intervention Type
Drug
Intervention Name
Description
Placebo daily for 12 weeks
Arm Group Label
Placebo
Eligibility
Criteria
Inclusion criteria:
1. physician diagnosis of asthma
2. on regular prescribed controller therapy for at least 3 months
3. positive methacholine challenge
4. age: ≥18 years
5. BMI ≥ 30 kg/m2
6. Sputum 8-isoprostane > 35.0 pg/ml
7. poorly controlled asthma defined as one of the following:
1. Asthma Control Test5 Score < 19, or
2. use of rescue inhaler on average > 2 uses/week for preceding month, or
3. nocturnal asthma awakening on average 1 or more times / week in preceding month,
or
4. ED/hospital visit or prednisone course for asthma in past six months
8. ability and willingness to provide informed consent
Exclusion criteria:
1. use of an investigational agent in the prior 30 days
2. physician diagnosis of chronic obstructive pulmonary disease
3. pregnancy/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. greater than 10 pack year smoking history
6. smoking within the last 6 months
7. use of the anti-oxidants idebenone or co-enzyme Q10 within 8 weeks
8. tendency to develop severe nose bleeds
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Anne E Dixon, MD |
Principal Investigator |
University of Vermont |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Duke University Durham North Carolina 27710 United States |
Not yet recruiting |
Last Name: Loretta Que, MD Role: Sub-Investigator | |
|
University of Vermont Burlington Vermont 05405 United States |
Not yet recruiting |
Last Name: Anne E Dixon, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Vermont
Investigator Full Name
Anne Dixon
Investigator Title
Professor of Medicine, Director of Pulmonary and Critical Care Medicine
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
MitoQ
Arm Group Type
Active Comparator
Description
MitoQ 40 mg per day for 12 weeks
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
placebo daily for 12 weeks
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
MIMDA
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double masked study
Study First Submitted
May 30, 2019
Study First Submitted Qc
July 17, 2019
Study First Posted
July 19, 2019
Last Update Submitted
July 22, 2019
Last Update Submitted Qc
July 22, 2019
Last Update Posted
July 24, 2019
ClinicalTrials.gov processed this data on December 05, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.