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NCT04512547CompletedPhase 2

Oxidative Stress in Asthma

Oxidative Stress and Regional Airway Remodeling and Fibrosis in Obese Asthma

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
49 (actual)
First submitted
20 Jul 2020
Start date
1 Apr 2021
Primary completion date
31 Jan 2025
Lead sponsor
Bastiaan Driehuys
Diseases
Obesity, Asthma
NCT number
NCT04512547

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 49
  • From 1 Apr 2021 to the primary completion date, 31 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Respiratory tract infection within the 4 weeks prior to Visit 0
  • Oral or systemic corticosteroid burst (for any indication) within the 4 weeks prior to Visit 0. One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 4- week washout prior to Visit 0
  • Asthma-related ER visit within the previous 4 weeks of Visit 0
  • Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
  • Asthma exacerbation requiring systemic corticosteroids within the 4 weeks prior to Visit 0
  • Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases
  • Participation in an intervention study (including, bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
  • Respiratory tract infection within the 4 weeks prior to Visit 0 Oral or systemic corticosteroid burst (for any indication) within the 4 weeks prior to Visit 0. One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 4-week washout prior to Visit 0
  • Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases
  • Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study

Other illness

  • History of ICU admission/intubation due to asthma in the past 1 year
  • History of bronchial thermoplasty
    • Non-Asthma Cohort EXCLUSION:
  • Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
  • Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine, shoulder circumference \>140 cm\*.) \*This measurement is not an absolute as it can vary based on weight distribution.

Lab values

  • Chronic renal failure (creatinine \> 2.0) at Visit 0
  • Chronic renal failure (creatinine \> 2.0) at Visit 0

Other

  • Asthma Cohort EXCLUSION:
  • Positive urine pregnancy test at Visit 0 or at any time during the study
  • Untreated sleep apnea
  • Unable or unlikely to complete study assessments in the opinion of the Investigator
  • Study intervention poses undue risk to patient in the opinion of the Investigator
  • Positive urine pregnancy test at Visit 0 or at any time during the study
  • Untreated sleep apnea
  • Unable or unlikely to complete study assessments in the opinion of the Investigator
  • Study intervention poses undue risk to patient in the opinion of the Investigator
    • Additional EXCLUSION Criteria for MRI

Who the study is looking for

  • 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 be given before any study procedures are performed.)
  • Women of childbearing potential must have a negative urine pregnancy test prior to MRI.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke Asthma Allergy and Airway Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.