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Asthma; EosinophilicReNORMNCT07174713

REverse LuNg Airway and Vascular RemOdeling in Asthma ReMission (ReNORM)

A study testing Biologic Therapy in people with Asthma; Eosinophilic, run by Western University, Canada at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In this program of research, the investigators aim to answer the question: In patients with asthma aged 18-80, how do the lung airways and vessels respond to biologic therapy and what role does age and asthma duration have in this response? While about 4.6 million Canadians live with asthma, ~5-10% of patients have… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Asthma; Eosinophilic
What is being tested?
Biologic Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
1 Oct 2026to Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants eligible for inclusion in this study must meet all the following criteria:
  • Participant understands study procedures and is willing 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 aged 18 to 80 years.
  • Either diagnosed with severe asthma (GINA Step 5) and newly eligible for biologic therapy (based on ACQ-5, current treatment, exacerbation history, and blood eosinophils in accordance with approved criteria for omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab), or a healthy volunteer with no history of chronic lung disease, matched by age and sex. Healthy participants must have a lifetime combustible tobacco and/or cannabis (including vaping) consumption of ≤5 pack-years.
  • 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:
Show all 17Show fewer
  • 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 8 weeks after last dose of study drug, with negative urine pregnancy test result at Visit 1-5.
  • 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 8 weeks after last dose

Who cannot join

  • Participants fulfilling any of the following criteria are not eligible for inclusion in this study:
  • 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.
  • Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
  • Participant is unable to perform spirometry or plethysmography maneuvers.
  • Participant is unable to perform MRI and CT breath-hold maneuvers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Robarts Research Institute; The University of Western Ontario

    London, Ontario, N6A 5B7

    Grace Parraga, PhD, 519-931-5265, gparraga@robarts.ca

Other trials in Canada

About this study

In this program of research, the investigators aim to answer the question: In patients with asthma aged 18-80, how do the lung airways and vessels respond to biologic therapy and what role does age and asthma duration have in this response? While about 4.6 million Canadians live with asthma, ~5-10% of patients have severe asthma meaning that multiple inhaled and systemic oral corticosteroid treatments have failed to improve symptoms and exacerbations, leading to lost work and school days and substantially diminished ability to participate in normal life. For such people, the vast majority of whom are middle aged and remember asthma as part of their entire lifespan, biologic immunomodulator therapies, which block the function of asthma inflammatory pathways, provide a final step-up therapy option. There is emerging evidence that prescribed in the right patient at the right time, the right biologic can result in clinical remission of asthma. While spontaneous clinical remission of asthma is rare, it has been documented in children in whom lung growth and remodeling is still possible. It remains unknown whether clinical remission in adults is accompanied by the reversal of pathologic remodeling, at the level of the airways and pulmonary vessels. This is critical to elucidate as investigators and physicians move forward with currently proposed criteria for "complete asthma remission". The inconvenient truth about asthma and age is that in older adult lungs, exposed to years of infection, exacerbations, smooth muscle remodeling and pulmonary vascular shunt, the mechanisms by which complete pathologic remission may be achieved are complex and poorly understood.

To address this knowledge gap, the investigators will evaluate 150 patients (Vancouver, Ottawa, Hamilton, London) (in three age tertiles 18-29; 30-59; 60-80) with severe asthma and 50 age- and sex matched healthy volunteers over 2-years using chest CT, MRI and pulmonary function tests. The investigators will use the pulmonary imaging measurements to generate an imaging-index of normal airway structure and function which will be compared with and significantly correlate with MR-guided bronchoscopic sample measurements made before and after 1-/2-years of treatment. The investigators will reveal the pathobiologic relationship between age, asthma duration, clinical remission and imaging normalization with direct comparison to histology-based airway measurements.

Being tested
Biologic Therapy
Keywords
Hyperpolarized Xenon MRI, Clinical Remission, Biologic Therapy, Airway Remodeling
Medical subject headings
Pulmonary Eosinophilia, Airway Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biologic TherapyBiological

    Participants with severe asthma (GINA 5) who are eligible to begin biologic therapy. Participants will undergo serial assessment with pulmonary imaging (CT, MRI), lung function testing, sputum collection, and symptom questionnaires. A subset of participants (~15%) will be randomized to undergo MRI-guided bronchoscopy with airway sampling at baseline and 2 years.

Study groups in NCT07174713
Study groupRoleWhat they receive
Asthma - Biologic TherapyExperimentalParticipants with severe asthma (GINA 5) who are eligible to begin biologic therapy. Participants will undergo serial assessment with pulmonary imaging (CT, MRI), lung function testing, sputum collection, and symptom questionnaires. A subset of participants (~15%) will be randomized to undergo MRI-guided bronchoscopy with airway sampling at baseline and 2 years.
Receives: Biological: Biologic Therapy
Healthy ControlNo interventionAge- and sex-matched healthy participants with no history of lung disease. Participants will undergo pulmonary imaging (CT, MRI) and lung function testing at baseline and follow-up for comparison with the asthma group. No therapeutic intervention will be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine extent of imaging-based remission in patients with severe asthma following 1 and 2 years of biologic therapy

    Measured using 129Xe ventilation defect percent (VDP)

    Measured: from baseline to year 1 and year 2

  2. Measure the extent and timing of clinical remission in patients with severe asthma as measured by changes in spirometry measurements of FEV1 and FVC

    Measured using forced expiratory volume in 1 second and forced vital capacity

    Measured: from baseline to 1 year and 2 years

  3. To determine the extent and timing of clinical remission in patients with severe asthma using symptoms scores of ACQ-5 and ACT

    Measured using changes in asthma control questionnaire and asthma control test

    Measured: From baseline to 1 year and 2 years

  4. Determine the extent and timing of imaging-based remission in patients with severe asthma using CT airway and vessel morphology

    Measured using computed tomography (CT) airway and vessel metrics

    Measured: From baseline to 1 year and 2 years

  5. To determine the extent and timing of clinical remission using the clinical outcome of frequency of asthma exacerbations in patients with severe asthma

    Measured using the number of asthma exacerbations

    Measured: from baseline to 1 year and 2 years

  6. To determine the extent and timing of clinical remission of patients with severe asthma using the clinical outcome of OCS use

    Measured by the frequency of oral corticosteroid usage

    Measured: From baseline to 1 year and 2 years

  7. Determine the extent and timing of clinical remission in patients with severe asthma as measured by sputum and blood eosinophil counts

    Measured using blood and sputum eosinophil counts

    Measured: From baseline to 1 year and 2 years

Secondary outcomes (17)
  1. Timing and proportion of patients achieving clinical remission after biologic treatment as measured by FEV1 and FVC.

    Measured using forced expiratory volume at 1 second and forced vital capacity.

    Measured: From baseline to 1 year and 2 years

  2. To determine the timing and proportion of patients achieving clinical remission as measured by ACQ-5 and ACT questionnaires.

    Measured by asthma control questionnaire and asthma control test questionnaire scores.

    Measured: From baseline to 1 year and 2 years

  3. Determine the timing and proportion of patients with severe asthma achieving clinical remission after biologic treatment using FeNO.

    Measured using fractional exhaled nitric oxide (FeNO)

    Measured: From baseline to 1 year and 2 years

  4. Determine the timing and proportion of patients with severe asthma achieving clinical remission using DLco.

    Measured using diffusing capacity of the lung for carbon monoxide (DLco)

    Measured: From baseline to 1 year and 2 years

  5. Determine the timing and proportion of patients with severe asthma achieving clinical remission after biologic treatment using SGRQ score.

    Measured using St. George's Respiratory Questionnaire (SGRQ) score.

    Measured: From baseline to 1 year and 2 years.

  6. Determine the timing and proportion of patients with severe asthma achieving clinical remission on biologic treatment using AQLQ scores.

    Measured using the Asthma Quality of Life Questionnaire (AQLQ) score.

    Measured: From baseline to 1 year and 2 years

  7. Determine the timing and proportion of patients with severe asthma achieving imaging normalization after biologic treatment using 129-Xe MRI VDP

    Measured using the changes in 129-xenon MRI ventilation defect percent (VDP)

    Measured: From baseline to 1 year and 2 years

  8. Determine the timing and proportion of patients with severe asthma achieving imaging normalization after biologic treatment using CT metrics

    Measured using computed tomography (CT) mucus-score, airway dimensions and vascular pruning

    Measured: From baseline to 1 year and 2 years

  9. Determine the timing and proportion of patients with severe asthma achieving imaging normalization after biologic treatment using DLco.

    Measured using diffusing capacity of the lung for carbon monoxide (DLco)

    Measured: From baseline to 1 year and 2 years

  10. Determine the timing and proportion of patients with severe asthma achieving imaging normalization after biologic treatment using RV/TLC

    Measured using the ratio of residual volume to total lung capacity (RV/TLC)

    Measured: From baseline to 1 year and 2 years

  11. Determine the timing and proportion of patients with severe asthma achieving imaging normalization after biologic treatment using FRC.

    Measured using functional residual capacity (FRC).

    Measured: From baseline to 1 year and 2 years

  12. Determine the relationships between clinical and imaging remission and generate predictive models for their achievement using changes in VDP

    Measured using ventilation defect percent (VDP)

    Measured: from baseline to 12-weeks and 2-years

  13. Determine the relationship between clinical and imaging remission and generate predictive models for their achievement using changes in CT.

    Measured using computed tomography (CT) airway wall thickness, mucus metrics

    Measured: From baseline to 12-weeks and 2-years

  14. Determine the relationships between clinical and imaging remission and generate predictive models for their achievement using FeNO.

    Measured using forced exhaled nitric oxide (FeNO).

    Measured: From baseline to 12-weeks and 2-years

  15. Determine the relationships between clinical and imaging remission and generate predictive models for their achievement using ACQ-5 and ACT scores.

    Measured using asthma control questionnaire and asthma control test scores.

    Measured: From baseline to 12-weeks and 2-years.

  16. Determine the relationships between clinical and imaging remission and generate predictive models for their achievement using sputum biomarkers.

    Measured using sputum eosinophil and cell count values

    Measured: From baseline to 12-weeks and 2-years

  17. Determine the relationships between clinical and imaging remission and generate predictive models for their achievement using exacerbation history.

    Measured using patient's reported exacerbation history.

    Measured: From baseline to 12-weeks and 2-years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel assignment of participants to one of two arms: (1) patients with severe asthma initiating biologic therapy, and (2) healthy volunteers serving as controls. Asthma patients are followed over 2 years to assess clinical, imaging, and histologic responses to biologic treatment. A randomized subset of asthma participants undergoes MRI-guided bronchoscopy to correlate imaging with histopathology.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174713
Sponsor's protocol ID
ROB0061
Acronym
ReNORM
Status last verified
Jul 2025
First submitted
8 Aug 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Biologic Therapy in people with Asthma; Eosinophilic, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace Parraga, PhD (519-931-5777 ext. 24197, gparraga@robarts.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine extent of imaging-based remission in patients with severe asthma following 1 and 2 years of biologic therapy (time frame: from baseline to year 1 and year 2). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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