Dupilumab for Asthma
Phase-Based Progress Estimates
Effectiveness
Safety
Asthma
Dupilumab - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will test whether the drug dupilumab can improve mucus clearance in asthma patients.
Treatment Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Measured from baseline to 12 weeks after start of treatment
Week 12
Change in mucociliary clearance (MCC) rate
Week 12
Change in ACT score
Change in FEV1% predicted
Change in mucus plugging score by CT
Change in sputum eosinophils and T2 gene mean
Peripheral and central lung MCC90, MCC240, AAC90
Whole lung MCC90, AAC90
Trial Safety
Trial Design
2 Treatment Groups
Dupilumab
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: Dupilumab · Has Placebo Group · Phase 4
Dupilumab
Drug
ActiveComparator Group · 1 Intervention: Dupilumab · Intervention Types: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured from baseline to 12 weeks after start of treatment
Who is running the clinical trial?
Sally E. Wenzel MDLead Sponsor
4 Previous Clinical Trials
765 Total Patients Enrolled
4 Trials studying Asthma
765 Patients Enrolled for Asthma
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:, OR on a leukotriene modifier
Asthma that is moderate to severe and requires treatment with high doses of inhaled corticosteroids (ICS) to control symptoms, OR treatment with a leukotriene modifier.
If your forced vital capacity (FVC) is less than 75%, then this means that your FEV1 is also below the normal range.
An asthma control test (ACT) score of less than 20 suggests that your asthma is not well controlled.
The text states that if a person has a reversible airflow limitation that is less than 12% at screening or within the past 2 years, or if they have a positive methacholine challenge test within the past 2 years, or if they have a positive methacholine challenge during screening, then they are not eligible to participate in the study.
:
A blood test shows that the number of eosinophils in your blood is more than 300 cells per mm3.
for up to one year were not associated with an increased risk of bone loss
Inhaled steroid doses of 500mcg or more per day for up to one year were not associated with an increased risk of bone loss.
is associated with asthma
If someone's FeNO level is >25 parts per billion, it is associated with asthma.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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