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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitoQ | Active Comparator | MitoQ 40 mg per day for 12 weeks |
|
| Placebo | Placebo Comparator | placebo daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoquinol | Drug | Mitoquinol (MitoQ) 40 mg per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Airway Reactivity | 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 | Through study completion, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Test (ACT) | To collect data on asthma symptoms measured by asthma control questionnaire with units on a scale from 5-25 (the lower the score, the worse the asthma symptoms) | Through study completion, 12 weeks |
| Number of Participants With Adherence at 12 Weeks |
Not provided
Inclusion criteria:
participant reported physician diagnosis of asthma
participant reported on regular prescribed controller therapy for at least 3 months
positive methacholine challenge (as determined by spirometry PD20 or oscillometry PD50 ≤ 4.0 mg/ml at visit 2)
age: ≥18 years
BMI ≥ 30 kg/m2 (at visit 1)
poorly controlled asthma defined as one of the following:
ability and willingness to provide informed consent
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne E Dixon, MD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States | ||
| University of Vermont |
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Run in period after screening prior to randomization 9 participants excluded 6 screen fails (2 low lung function, 3 negative methacholine, 1 unable to perform study procedures 3 withdrew (1 lack of transport, 2 research burden)
Recruitment period 1/1/2020-12/1/2023 Recruitment locations: two pulmonary clinics at academic medical centers in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | MitoQ | MitoQ 40 mg per day for 12 weeks |
| FG001 | Placebo | placebo daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MitoQ | MitoQ 40 mg per day for 12 weeks |
| BG001 | Placebo | placebo daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Airway Reactivity | 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 | 2 participants in the MitoQ group withdrew 4 participants in the placebo group did not perform methacholine at 12 week visit: Lung function too low (FEV1 less than 60%), and participants unable to complete testing | Posted | Median | Inter-Quartile Range | μg methacholine | Through study completion, 12 weeks |
|
From enrollment until study end (after 12 weeks on study drug)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MitoQ | MitoQ 40 mg per day for 12 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Dixon, Professor of Medicine | University of Vermont | 802 847 0000 | anne.dixon@uvmhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2022 | Nov 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C429015 | mitoquinol |
| C429014 | mitoquinone |
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Double masked study
| Placebo oral tablet | Drug | Placebo daily for 12 weeks |
|
Adherence determined from pill counts (classified as adherent if used at least 80% of predicted pills) |
| Through study completion, 12 weeks |
| Change in Asthma Quality of Life Questionnaire Score | The Marks Asthma Quality of Life Questionnaire (Marks AQLQ). units on a scale from 1 to 5. Higher score indicates better quality of life | Through study completion, 12 weeks |
| Change in FEV1 | Change in forced expiratory volume in one second between baseline and 12 week visit | Through study completion, 12 weeks |
| Change in FVC | Change in forced vital capacity from baseline to 12 weeks measured in liters | Through study completion, 12 weeks |
| Burlington |
| Vermont |
| 05405 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Asthma Control Test | units on scale 5-25, high score indicative of better control | Mean | Standard Deviation | total score |
|
| Marks Asthma Quality of Life | Disease specific quality of life questionnaire: range 1-5, higher score indicative of better quality of life | Mean | Standard Deviation | score on questionnaire |
|
| Airway reactivity to methacholine | dose of methacholine producing a 20% decrease in FEV1 | one participant in the placebo group had poor quality test, and so could not be included in the analysis | Median | Inter-Quartile Range | μg methacholine |
|
| FEV1 | Forced expiratory volume in 1 second | Mean | Standard Deviation | liters |
|
| FVC | Forced vital capacity | Mean | Standard Deviation | liters |
|
| AX | Impedance (Ax, area under the reactance curve) | Median | Inter-Quartile Range | cm H20/L |
|
|
|
|
| Secondary | Change in Asthma Control Test (ACT) | To collect data on asthma symptoms measured by asthma control questionnaire with units on a scale from 5-25 (the lower the score, the worse the asthma symptoms) | 2 withdrew from mitoQ group | Posted | Median | Inter-Quartile Range | score | Through study completion, 12 weeks |
|
|
|
| Secondary | Number of Participants With Adherence at 12 Weeks | Adherence determined from pill counts (classified as adherent if used at least 80% of predicted pills) | Posted | Count of Participants | Participants | Through study completion, 12 weeks |
|
|
|
| Secondary | Change in Asthma Quality of Life Questionnaire Score | The Marks Asthma Quality of Life Questionnaire (Marks AQLQ). units on a scale from 1 to 5. Higher score indicates better quality of life | Posted | Median | Inter-Quartile Range | questionnaire score | Through study completion, 12 weeks |
|
|
|
| Secondary | Change in FEV1 | Change in forced expiratory volume in one second between baseline and 12 week visit | one participant unable to complete spirometry testing at 12 week visit | Posted | Median | Inter-Quartile Range | liters | Through study completion, 12 weeks |
|
|
|
| Secondary | Change in FVC | Change in forced vital capacity from baseline to 12 weeks measured in liters | one participant in the placebo group unable to perform lung function testing at 12 week visit | Posted | Median | Inter-Quartile Range | liters | Through study completion, 12 weeks |
|
|
|
| 20 |
| 0 |
| 20 |
| 12 |
| 20 |
| EG001 | Placebo | placebo daily for 12 weeks | 0 | 18 | 0 | 18 | 10 | 18 |
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| gastroesophageal reflux/ nausea | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|