Biomarkers put to the test for predicting asthma remission

NCT ID NCT07816718

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether specialized tests of airway inflammation and lung abnormalities can predict asthma remission and relapse better than standard clinical assessments. The trial enrolls adults with severe asthma who are starting biologic therapy. Participants are randomly assigned to receive either standard asthma care or a comprehensive management approach guided by biomarker results. Over 12 months, participants undergo questionnaires, lung function tests, blood collection, sputum analysis, and CT and MRI imaging.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a comprehensive biomarker-guided asthma management strategy using sputum cell analysis and imaging biomarkers
What this could lead to
If the approach works, doctors could use specialized airway and lung tests to predict which severe asthma patients will stay in remission and which may relapse, allowing more personalized treatment.
What could go wrong
This is a small study of 50 people over 12 months, so the findings may not apply broadly. Biomarkers may not reliably predict outcomes, and the extra tests could add burden without changing care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

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 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * • Patient understands study procedures and is will to participate in the study as indicated by the patient's signature. * Provision of written, informed consent prior to any study specific procedures. * Males and females ≥ 18 years of age. * Diagnosis of severe asthma, as defined by ATS/ERS guidelines (requiring high-dose ICS plus second controller and/or OCS, or uncontrolled despite this therapy). * Eligible for initiation of biologic therapy for treatment of asthma. * Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include: * True sexual abstinence * A vasectomized sexual partner * Implanon® * Female sterilization by tubal occlusion * Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS) * Depo-Provera™ injections * Oral contraceptive * Evra Patch™ * Nuvaring™ * Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and X weeks after last dose of study drug, with negative urine pregnancy test result at Visit 1 and Visit 5. * Male participants who are sexually active must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until X weeks after last dose. Exclusion Criteria: * • Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis). * Patients with incomplete medical records. * Patients who have received biologic treatment for asthma within the last 6 months. * Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist). * In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia. * Patients with contraindications to PFT, sputum induction, CT or MRI imaging. * Patients who are pregnant or breastfeeding. * Patients who are unable or unwilling to comply with study procedures.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • St. Joseph's Health Care London

    London, Ontario, N6A 4V2, Canada

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