Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma.

Phase 3

Waitlist Available

Led By Parameswaran Nair, MD, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between screening (week -4) and week 16.

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial is testing Dupilumab, a medication that reduces inflammation and mucus in the lungs. It targets people with a specific type of asthma that involves high levels of inflammation. The medication works by blocking certain proteins that cause these symptoms, helping to improve breathing and asthma control. Dupilumab is approved for treating asthma and other inflammatory diseases.

Eligible Conditions

Asthma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between screening (week -4) and week 16.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between screening (week -4) and week 16.

This trial's timeline: 3 weeks for screening, Varies for treatment, and between screening (week -4) and week 16. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients that achieve at least one doubling dose improvement in PC20 methacholine and/or a 50% reduction in FEV1 reversibility after bronchodilator.

Secondary study objectives

Change in Asthma Control Questionnaire-5 (ACQ-5)

Change in Asthma Control Questionnaire-5 (AQLQ)

Change in Asthma Control Test (ACT)

+6 more

Other study objectives

Change in CT airway remodeling and airway mucus scores (n=12 in each arm).

Change in MRI ventilation heterogeneity (n=12 in each arm).

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: dupilumabActive Control1 Intervention

Dupilumab 300 mg subcutaneously (SC) every 2 weeks as an investigational drug. For those randomized to dupilumab, a loading dose of 600 mg will be given only at randomization/Visit 2. Sterile dupilumab of will be provided in 150 mg/mL in glass prefilled syringes (2.25 mL total volume) to deliver 300 mg in 2 mL.

Group II: matched placeboPlacebo Group1 Intervention

Sterile placebo for dupilumab will be provided in identically matched glass prefilled syringes to deliver 2 mL.

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