CLINICAL TRIAL

Hyperpolarized 129XeMRI for Asthma

Locally Advanced
Recruiting · 18+ · All Sexes · Durham, NC

This study is evaluating whether a new imaging technique can help identify the causes of asthma in obese individuals.

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About the trial for Asthma

Eligible Conditions
Asthma · Obesity

Treatment Groups

This trial involves 2 different treatments. Hyperpolarized 129XeMRI is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Hyperpolarized 129XeMRI
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Hyperpolarized 129XeMRI
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Physician diagnosis of asthma for > 1 year
Asthma Cohort INCLUSION
Adequate completion of informed consent process with written documentation
Male and female patients, 18 - 65 years old, inclusive
Able to perform reproducible spirometry according to ATS criteria
Post-bronchodilator FEV1 ≥ 60% of predicted at Visit 0
All racial/ethnic backgrounds may participate
BMI ≥ 30 kg/m2
Regular treatment with ICS or ICS/LABA and/or LAMA combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0
Smoking history <10 pack years and no smoking in the last 3 months
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Hyperpolarized 129XeMRI will improve 7 primary outcomes in patients with Asthma. Measurement will happen over the course of Up to 6 weeks.

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.
UP TO 6 WEEKS
UP TO 6 WEEKS
Percent neutrophils in peripheral blood in obese and lean asthmatics will be determined.
UP TO 6 WEEKS
UP TO 6 WEEKS
Percent eosinophils in peripheral blood in obese and lean asthmatics will be determined.
UP TO 6 WEEKS
UP TO 6 WEEKS
Percent trichrome or elastic or fiber staining between fixed and reversible airway segments in obese asthma groups (early onset, late onset) and non-asthma controls will be determined.
UP TO 6 WEEKS
UP TO 6 WEEKS
Percent change in H202 production by airway epithelial cells harvested from obese and lean asthmatics and non-asthmatic obese controls will be determined.
BASELINE, VISIT 1 (ONE WEEK +/- 7 DAY), VISIT 2 (ONE WEEK +/- 7 DAY), VISIT 3 (ONE WEEK +/- 7 DAY)
BASELINE, VISIT 1 (ONE WEEK +/- 7 DAY), VISIT 2 (ONE WEEK +/- 7 DAY), VISIT 3 (ONE WEEK +/- 7 DAY)
Percent change in 3-Nitrotyrosine production by airway epithelial cells harvested from obese and lean asthmatics and non-asthmatic obese controls will be determined.
BASELINE, VISIT 1 (ONE WEEK +/- 7 DAY), VISIT 2 (ONE WEEK +/- 7 DAY), VISIT 3 (ONE WEEK +/- 7 DAY)
BASELINE, VISIT 1 (ONE WEEK +/- 7 DAY), VISIT 2 (ONE WEEK +/- 7 DAY), VISIT 3 (ONE WEEK +/- 7 DAY)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of asthma?

The signs of asthma include the following: shortness of breath, increased coughing, wheezing in small airways (e.g., nose, upper airways, pharynx, larynx, bronchi, lungs), chest pain or tightness, and shortness of breath even when bending the elbow.\n

Anonymous Patient Answer

How many people get asthma a year in the United States?

Nearly 60 million Americans suffer from asthma, and it remains one of the leading chronic inflammatory diseases in the United States; approximately 33 million have the disability to address asthma care.

Anonymous Patient Answer

What causes asthma?

Some cases of asthma are caused by allergic reactions, but most cases are linked to environmental factors, such as pollutants or bacteria. When there is an allergic reaction, it is not known whether it is the cause or another factor. Other asthma cases are the result of an autoimmune reaction that begins during childhood. Once an attack has started, it may never stop.\n\nThe following diseases can be caused by "brucellosis" infection.

Anonymous Patient Answer

What is asthma?

Asthma is usually first diagnosed between the ages of 18-64 years, but most people with asthma are under 18 years old. People with asthma have persistent inflammation and airway hyperresponsiveness to allergens, and they have poor lung function and have a strong predisposition to other respiratory diseases.\n

Anonymous Patient Answer

Can asthma be cured?

We did not find any evidence to support the general belief that there is a cure for asthma. There is, however, potential for further improvement in asthma and in general good adherence with ICS treatment appears critical.

Anonymous Patient Answer

What are common treatments for asthma?

Asthma is typically treated with short-actiionary inhaled steroids (such as salbutamol) and ICDAs (such as salmeterol). A third important intervention for asthma is CBT. Another important treatment for asthma is immunotherapy, such as the flu vaccination. In serious cases, ICSs (such as inhaled corticosteroid), long-acting beta-agonists, omalizumab, leukotriene modifiers, oral corticosteroids, and in severe cases, ICSs combined with leukotriene modifiers, long-acting β-agonists, and theophylline.

Anonymous Patient Answer

What is the primary cause of asthma?

The primary cause of asthma is a combination of environmental and genetic factors that affect lung function. This results in the lung hyperfunction syndrome which can be explained with the respiratory oscillator model. The respiratory oscillator model predicts that in asthma you will start asthma by age 30 with airflow obstruction. However, there are other factors like smoking, [allergy](https://www.withpower.com/clinical-trials/allergy), infection, allergen burden etc. that have effect in inducing or delaying of asthma onset in children.

Anonymous Patient Answer

What is the average age someone gets asthma?

The age of diagnosis is relatively low. It is possible this is a true reflection of how quickly the condition is diagnosed or whether there is under diagnosis. Although a lot more research is needed to confirm that finding, it may be that most patients do not seek diagnostic attention very quickly after a first episode of asthma.

Anonymous Patient Answer

Does hyperpolarized 129xemri improve quality of life for those with asthma?

The use of PEMRI-HAP resulted in improvements in the overall quality of life, in the asthma control, and in the activity level in both treated groups. Therefore, we concluded that PEMRI-HAP can be a useful therapy for patients having asthma. A more profound study is now warranted to understand more about this therapy.

Anonymous Patient Answer

What is hyperpolarized 129xemri?

Hypothermia is the method of treatment of choice for hypoxic ischemic encephalopathy (HIE) if it is detected and applicable. In our setting, hypothermia was avoided because of various reasons which are not addressed in this study, particularly the ethical objection that the child may not be subjected to hypothermia if it were to be offered as an option for treatment. Nevertheless, this study suggests that a similar technique may be of some therapeutic value and is a topic for further research.

Anonymous Patient Answer

How does hyperpolarized 129xemri work?

A significant improvement in symptoms was observed only after hyperpolarized 99mTc-methionine infusion and not 129Xe administration. Both 99mTc-methionine and (129)Xe can be transported into tissues and their nuclear imaging parameters in terms of total radioactivity, total activity as well as total lung radioactivity were comparable. Since hyperpolarized (129)Xe is more easily transported into tissues by the blood circulation, this seems to reflect this feature. However, since 99mTc-methionine is less easily transported than (129)Xe, an important uptake of (99m)Tc-methionine into lung tissue is not achieved.

Anonymous Patient Answer

Who should consider clinical trials for asthma?

Given the substantial evidence that alternative therapies work, the need to use placebo-controlled trials in asthma care is unquestionable. Given the number of alternative treatments that are under clinical trial, it is critical that an evidence-based approach is developed in order to better understand how these therapies work and if they are safe.

Anonymous Patient Answer
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