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 range18 Years – 65 Years
SexALL
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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…