Obesity and asthma: scientists probe hidden airway damage
NCT ID NCT04512547
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at why obese people with asthma often have more severe symptoms and don't respond well to standard treatments. Researchers used special MRI scans and genetic analysis to examine airway changes in 49 obese adults with asthma. The goal was to better understand the role of oxidative stress and inflammation, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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49 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 be given before any study procedures are performed.) * Women of childbearing potential must have a negative urine pregnancy test prior to MRI. EXCLUSION Criteria Asthma Cohort EXCLUSION: * 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 * History of ICU admission/intubation due to asthma in the past 1 year * 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 * Chronic renal failure (creatinine \> 2.0) at Visit 0 * Positive urine pregnancy test at Visit 0 or at any time during the study * Untreated sleep apnea * 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 * 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 * History of bronchial thermoplasty Non-Asthma Cohort EXCLUSION: * 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 * Chronic renal failure (creatinine \> 2.0) at Visit 0 * Positive urine pregnancy test at Visit 0 or at any time during the study * Untreated sleep apnea * 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 * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27705, United States
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Other studies related to the condition(s) this trial covers.
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