Oxidative Stress in Asthma (NCT04512547) | Clinical Trial Compass
CompletedPhase 2
Oxidative Stress in Asthma
United States49 participantsStarted 2021-04-01
Plain-language summary
40% of all asthma patients in the US are obese. Obese asthmatics have more severe disease than lean asthmatics and do not respond as well to conventional anti-inflammatory therapies. This proposal will utilize 3D functional imaging with 129XeMRI and single cell RNA sequencing to study mechanisms driving regional airway remodeling and fibrosis in obese asthma subjects and in preclinical models of obese asthma.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Asthma Cohort INCLUSION
* Adequate completion of informed consent process with written documentation
* Male and female patients, 18 - 65 years old, inclusive
* Physician diagnosis of asthma for \> 1 year
* 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
* Late onset asthma: Age of asthma onset (diagnosis) ≥12 years;
* FeNO \< 25 ppb at Visit 0
* Negative allergen skin test
* Early onset asthma: Age of asthma onset (diagnosis) \<12 years
* FeNO ≥ 25 ppb at Visit 0
* Positive allergen skin test
Non-Asthma Cohort INCLUSION
* No history of asthma or other chronic lung diseases
* Male and female patients, 18 - 65 years old, inclusive
* Not currently smoking or using other forms of tobacco-related products (including vaping)
* Smoking history \<10 pack years and no smoking in the past 3 months
* FEV1 \> 80% of predicted and FEV1/FVC \> lower limit of normal.
* Ability to sign consent
* BMI ≥ 30 kg/m2
* Negative allergen skin test
Additional INCLUSION Criteria for MRI
* Outpatients of either gender, age \> 18
* Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.