The purpose of this study is to compare the use of an investigational drug, called PT027, with PT007 on severe asthma exacerbations in adolescent participants aged 12 to < 18 years with asthma. This study is looking at how effective and safe PT027 is compared with PT007 in adolescents with asthma. Adolescents are at risk for poor outcomes in asthma, including increased burden of emergency room visits.
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Description
Eligibility Criteria
12-18 Years Old; Has a Body Mass Index (BMI) of less than 40kg/m²; Confirmed clinical diagnosis of asthma at least 12 months before Visit 1; A documented history of at least one severe asthma exacerbation within 12 months before Visit 1
Duration
The anticipated duration of the study is approximately 58 weeks, including a 1 to 4 week screening period, followed by a 52 week treatment period, and a 1 to 2 week follow-up period.
Intervention
Participants who meet the eligibility criteria will be randomly assigned to one of the following 2 treatment groups in a 1:1 ratio on top of their own usual maintenance therapy: 1) PT027 2) Pt007
Categories
- Youth Clinical Trial