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Hyperpolarized 129XeMRI Imaging for Severe Asthma in Obesity
Phase 2
Recruiting
Led By Loretta Que, MD
Research Sponsored by Bastiaan Driehuys
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Asthma Cohort: Late onset asthma: Age of asthma onset (diagnosis) ≥12 years
Non-Asthma Cohort: Not currently smoking or using other forms of tobacco-related products (including vaping)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)
Awards & highlights
Study Summary
This trial will use 3D imaging and RNA sequencing to study why obese asthmatics have more severe disease, in hopes of finding better ways to treat it.
Who is the study for?
This trial is for adults aged 18-65 with asthma and a BMI ≥30 kg/m2, who have been on stable asthma medication for at least 3 months. Non-smokers or those who haven't smoked in the last 3 months are eligible. Participants must be able to perform spirometry tests and give informed consent. Pregnant women, individuals with significant illnesses like heart disease or uncontrolled diabetes, or those unable to complete study assessments are excluded.Check my eligibility
What is being tested?
The trial is studying how obesity affects severe asthma by using advanced imaging called Hyperpolarized 129XeMRI and single cell RNA sequencing. It aims to understand airway remodeling and fibrosis in obese asthmatics compared to lean ones, potentially leading to better treatments.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from lying still during MRI scans, anxiety due to claustrophobia inside the MRI machine, allergic reactions if contrast agents are used, and minor bruising from blood draws.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My asthma was diagnosed when I was 12 years old or older.
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I do not smoke or use tobacco/vaping products.
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I have asthma and my BMI is 30 or higher.
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I can do a breathing test as per standard guidelines.
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I have been diagnosed with asthma for over a year.
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I am between 18 and 65 years old and do not have asthma.
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My BMI is 30 or higher and I do not have asthma.
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I have never had asthma or other long-term lung problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Leptin stimulated human airway fibroblast invasiveness will be determined by counting mean numbers of invading fibroblasts in obese and lean asthmatics and non-asthmatic obese controls.
Percent change in 3-Nitrotyrosine production by airway epithelial cells harvested from obese and lean asthmatics and non-asthmatic obese controls will be determined.
Percent change in H202 production by airway epithelial cells harvested from obese and lean asthmatics and non-asthmatic obese controls will be determined.
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Obese AsthmaticsExperimental Treatment1 Intervention
Obese patients that come to Duke that have been diagnosed with Asthma will be approached.
Group II: Obese Non-AsthmaticsActive Control1 Intervention
The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.
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Who is running the clinical trial?
Bastiaan DriehuysLead Sponsor
14 Previous Clinical Trials
1,041 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,499 Total Patients Enrolled
58 Trials studying Asthma
8,267 Patients Enrolled for Asthma
Loretta Que, MDPrincipal InvestigatorDuke
5 Previous Clinical Trials
197 Total Patients Enrolled
3 Trials studying Asthma
168 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had bronchial thermoplasty for my asthma.You have a negative result on an allergy skin test.If you are a woman, you are pregnant when you start the study or become pregnant during the study.I visited the ER for my asthma within the last 4 weeks.I have chronic kidney issues with creatinine levels above 2.0.I have asthma and my sleep apnea has not been treated.I have a serious health condition such as heart disease, cancer, or uncontrolled diabetes.I have had 3 or more severe asthma attacks in the last year.Your breath test result shows high levels of FeNO (a marker for inflammation in the lungs) at the start of the study.I have not been in a drug study or had certain lung procedures in the last 30 days.Your lung function test results show that you don't have asthma.I have had a respiratory infection in the last 4 weeks.My kidney function is impaired with a creatinine level over 2.0.You have metal in your eye, are very scared of small spaces, have trouble lying down, or have a very large shoulder size that may not fit in the MRI machine.You are pregnant and the test shows it.I have sleep apnea that has not been treated.My asthma was diagnosed when I was 12 years old or older.I am between 18 and 65 years old and have asthma.You have smoked less than 10 packs of cigarettes in your life and have not smoked in the last 3 months.My asthma was diagnosed before I turned 12.I do not smoke or use tobacco/vaping products.If you have asthma, your FeNO (a measure of airway inflammation) needs to be less than 25 parts per billion at the start of the trial.I am over 18 years old and not hospitalized.I have asthma and no severe illnesses like heart disease or uncontrolled diabetes.Your lung function after using a bronchodilator is at least 60% of what is expected for someone your age and size.I have asthma and my BMI is 30 or higher.I have not participated in any drug trials or had certain procedures for my asthma in the last 30 days.I can do a breathing test as per standard guidelines.I was admitted to the ICU or intubated for asthma in the last year.I have been diagnosed with asthma for over a year.You have smoked less than 10 packs of cigarettes in your life and have not smoked in the past 3 months.I have asthma and needed steroids for an attack in the last 4 weeks.You have a positive skin test for allergens.I haven't had a respiratory infection or taken steroids in the last 4 weeks.I have not taken oral or systemic steroids for any reason in the last 4 weeks.I have been on stable asthma medication for at least 3 months.I am between 18 and 65 years old and do not have asthma.My BMI is 30 or higher and I do not have asthma.I have never had asthma or other long-term lung problems.You do not have a positive reaction to allergen skin tests.
Research Study Groups:
This trial has the following groups:- Group 1: Obese Non-Asthmatics
- Group 2: Obese Asthmatics
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Hyperpolarized 129XeMRI obtained permission from the FDA to be used?
"There is some data attesting to Hyperpolarized 129XeMRI's safety, which earns it a 2 out of 3 on our team's scale. As this is only Phase 2 trial, no clinical efficacy has been established yet."
Answered by AI
Are additional participants currently being sought for the trial?
"According to clinicaltrials.gov, this medical study is still open for recruitment. It was posted on the 1st of April 2021 and has seen its most recent update as of December 10th 2021."
Answered by AI
Is eligibility for this research confined to individuals aged below eighty?
"To be eligible for this treatment, potential patients must be between 18 and 65 years old. There are 311 trials open to participants younger than 18, as well as 781 studies available for those over the age of 65."
Answered by AI
Could I potentially join this clinical investigation?
"This medical research is in search of 40 participants between the ages of 18 and 65 who have been diagnosed with asthma. Eligible candidates are encouraged to apply for this clinical trial."
Answered by AI
How many participants are currently being monitored in this experiment?
"Affirmative. Clinicaltrials.gov suggests that this medical trial is actively seeking participants for its research, which was first posted on April 1st 2021 and recently updated on December 10th 2021. 40 individuals need to be enrolled from a single location."
Answered by AI
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