Biologic Therapy for Asthma

(ReNORM Trial)

Overseen By Angela Wilson, RRT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Must be taking: Biologics

Disqualifiers: Implanted devices, Claustrophobia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how biologic therapy, which uses substances from living organisms, affects lung airways and vessels in people with severe asthma. Researchers aim to determine if these treatments can lead to asthma remission, particularly in adults with lifelong asthma. The trial includes both asthma patients and healthy volunteers to assess the treatment's impact on lung structure and function. Individuals with severe asthma who have not found relief from other treatments and frequently miss work or school due to symptoms might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for severe asthma.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that biologic therapy for asthma is likely to be safe?

In a previous study, data from the World Health Organization's global database showed that treatments for severe asthma, known as biologic therapies, are generally safe. These treatments help by blocking certain pathways that cause inflammation in asthma. Research has shown they are well-tolerated, with most side effects being mild. Some patients might experience reactions at the injection site, headaches, or mild infections, but serious side effects are rare.

Further studies have confirmed the safety of these biologics in both children and adults with severe asthma. The Global Initiative for Asthma (GINA) recommends using them only for severe cases, emphasizing their safety when other treatments haven't worked. This suggests that biologic therapies are a promising option for those with severe asthma, offering hope with a proven safety record in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Biologic therapy for asthma is unique because it targets the underlying immune response, which is not the focus of most traditional asthma treatments. While standard asthma treatments often include inhalers that open airways or reduce inflammation, biologics work by blocking specific molecules involved in the asthma inflammatory pathway, offering a more targeted approach. Researchers are excited about this treatment because it has the potential to provide relief for individuals with severe asthma who don't respond well to conventional therapies. By addressing the root cause of asthma symptoms, biologics could significantly improve quality of life for those with the most severe cases.

What evidence suggests that biologic therapy might be an effective treatment for asthma?

Research has shown that biologic therapies can greatly help people with severe asthma. In this trial, participants with severe asthma will receive biologic therapy, which reduces asthma attacks, hospital visits, and the need for regular steroid medication. Studies have found that starting biologic treatments can lead to better lung function and more control over asthma symptoms in the long run. However, effectiveness can vary based on specific patient factors, such as levels of eosinophils, a type of white blood cell. For those with low eosinophil levels, some biologics might not improve asthma outcomes. Overall, biologics offer a promising option for those who haven't found relief with other treatments. ^{2 6 7 8 9}

Who Is on the Research Team?

Grace Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Are You a Good Fit for This Trial?

The ReNORM trial is for adults aged 18-80 with severe asthma, where standard treatments haven't worked. It's looking at people in different age groups to understand how biologic therapy affects lung remodeling. Healthy volunteers are also needed for comparison.

Inclusion 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

I am between 18 and 80 years old.

Exclusion Criteria

Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed

Subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT

Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including pulmonary imaging (CT, MRI), lung function testing, and symptom questionnaires

1-2 weeks

Treatment

Participants with severe asthma receive biologic therapy and undergo serial assessments with pulmonary imaging, lung function testing, and symptom questionnaires

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging and lung function tests at 1 and 2 years

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biologic Therapy

Trial Overview This study tests if biologic therapies can reverse lung damage in severe asthma patients. Participants will undergo chest CTs, MRIs, and pulmonary function tests over two years to see if treatment aligns airway structure and function with healthy norms.

How Is the Trial Designed?

Group I: Asthma - Biologic Therapy Experimental Treatment 1 Intervention

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.

Group II: Healthy Control Active Control 1 Intervention

Age- 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.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39778920/

Biologics in severe asthma: a state-of-the-art review Biologic therapies play a significant role in reducing exacerbations, hospitalisations and the need for maintenance systemic steroids.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2212534525000322

Long-term, real-world effectiveness of biologics for severe ... Initiation of a BIO was associated with significant improvements in long-term lung function and asthma control among patients with severe uncontrolled asthma.

3. ginasthma.org ginasthma.org/wp-content/uploads/2024/05/GINA-2024-Strategy-Report-24_05_22_WMS.pdf

GINA-2024-Strategy-Report-24_05_22_WMS.pdf The reader acknowledges that this report is intended as an evidence-based asthma management strategy, for the use.

4. dovepress.com dovepress.com/real-world-biologic-use-patterns-in-severe-asthma-20152021-the-clear-s-peer-reviewed-fulltext-article-POR

Real-World Biologic Use Patterns in Severe Asthma, 2015 ... The CLEAR study aimed to assess real-world biologic use patterns and associated clinical outcomes in patients receiving care for severe asthma.

5. annallergy.org annallergy.org/article/S1081-1206(22)02000-2/fulltext

A comparison of the effectiveness of biologic therapies for ... For patients with low eosinophils, biologics probably do not improve asthma outcomes. For these patients, tezepelumab (MD, 0.1 L [95% CI, 0-0.19]) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38489062/

Safety of Biological Therapies for Severe Asthma The aim of this study was to provide an overview of safety data of biologics for severe asthma using VigiBase, the World Health Organization global ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1081120625003953

Real-Life Evaluation of Biologics in Pediatric Severe ... These findings reinforce the established safety profile of biologics in pediatric asthma, as noted in other clinical and real-life studies6-8.

8. ginasthma.org ginasthma.org/wp-content/uploads/2024/11/GINA-Severe-Asthma-Guide-2024-WEB-WMS.pdf

DIFFICULT-TO-TREAT & SEVERE ASTHMA However, GINA recommends the use of biologic therapy only for patients with severe asthma, and only after treatment has been optimized. For any biologic ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11055782/

Safety of Biological Therapies for Severe Asthma The aim of this study was to provide an overview of safety data of biologics for severe asthma using VigiBase, the World Health Organization global ...