Status:
NOT_YET_RECRUITING
REverse LuNg Airway and Vascular RemOdeling in Asthma ReMission (ReNORM)
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Asthma; Eosinophilic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 an...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07174713
Start Date
October 1 2025
End Date
October 1 2030
Last Update
September 16 2025
Active Locations (1)
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1
Robarts Research Institute; The University of Western Ontario
London, Ontario, Canada, N6A 5B7