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Obesity and asthma: scientists probe hidden airway damage

NCT ID NCT04512547

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Apr 2021

Finished

Jan 2025

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Duke Asthma Allergy and Airway Center

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.