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PROSPERO (ML28528) (ADaM data (ADLB: lab test outcomes. All kinds of label…
PROSPERO (ML28528)
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Objectives
Secondary Objective
To evaluate the ability of a variety of individual and composite clinical outcomes to differentiate response in patients with allergic asthma initiating omalizumab treatment.
Exploratory Objectives
To evaluate time to response for different clinical outcomes in patients with allergic asthma initiating omalizumab treatment
To establish a tissue bank and blood repository for future biomarker correlation with different clinical outcomes (optional participation)
To evaluate the effect of omalizumab on biomarkers and the relationship of various biomarkers to one another, including the relationships over time between changes in biomarkers
Primary Objective
To evaluate baseline patient characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in patients with allergic asthma initiating omalizumab treatment.
Study design
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Length of study
LPLV is expected to occur 48 weeks (around 1 year) after the last patient is enrolled into the study.
Target population
Inclusion criteria
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Patients identified by the investigator as a candidate for treatment for allergic asthma with omalizumab
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Able and willing to provide written informed consent (in the case of a minor, consent must be given by the child’s parent or legally authorized representative)
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ADaM data
ADLB: lab test outcomes. All kinds of label variable. e.g. EOS, PERIOS, IGE, etc.
ADASM: asthma analysis data. Exacerbation during the study follow-up, hospitalizations, ER visit, etc.
ADASMH: asthma history data. Exacerbation/hospitalization/ER visit in 12 months/90 days
prior to study, etc.
ADZA: clinical findings. Contains the lung function variables, e.g. FEV1, FENO, FVC, FEVPRE, etc.
ADPRO: patient report outcomes. mainly contains ACTSCORE, WPAI, AQLQ(S), MiniRQLO values
ADSL: Subject level analysis data (baseline); baseline biomarker measure and flag for biomarker level.