Hyperpolarized xenon MRI in treatment of severe asthma by mepolizumab: toward earlier detection of individual patient responses
美泊利单抗治疗严重哮喘的超极化氙 MRI:早期检测个体患者的反应
基本信息
- 批准号:10400725
- 负责人:
- 金额:$ 38.75万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-06-01 至 2025-04-30
- 项目状态:未结题
- 来源:
- 关键词:AddressAffectAsthmaBiologicalBiological MarkersBiological ProductsBiological Response Modifier TherapyBolus InfusionBronchodilationBronchodilator AgentsChronic Obstructive Pulmonary DiseaseClinicalClinical ManagementClinical TrialsClinical assessmentsCystic FibrosisDataDefectDeveloped CountriesDevelopmentDiseaseDoseDrug TargetingEarly DiagnosisEtiologyEvaluationExhibitsExtrinsic asthmaGasesHealth Care CostsHealthcareImageImaging TechniquesImpairmentInhalationInterleukin-5LeadLeukotrienesLungMagnetic Resonance ImagingMagnetismMapsMeasurementMeasuresMethodsMolecularNoble GasesNuclearPathway interactionsPatient-Focused OutcomesPatientsPharmaceutical PreparationsPhysiologicalPlacebo EffectPopulationProcessPulmonary Function Test/Forced Expiratory Volume 1Pulmonary function testsQuestionnairesRefractoryRelaxationResolutionSavingsSeverity of illnessSignal TransductionSputumSteroidsStimulusSymptomsTechniquesTimeWorkXenonairway hyperresponsivenessairway inflammationasthmaticasthmatic patientbasecohortconventional therapycostcost outcomesefficacy evaluationeosinophileosinophilic asthmaimprovedimproved outcomeindividual patientindividual responseindividualized medicineineffective therapiesinhibitormepolizumabnew therapeutic targetpatient responsepredicting responseprimary endpointpulmonary functionresearch clinical testingrespiratoryrespiratory smooth muscleresponsespecific biomarkersstandard of caretreatment responseventilation
项目摘要
Project Summary
Patients with severe, refractory asthma constitute approximately 5% of all asthma patients but are responsible
for over 50% of all asthma-related healthcare costs. Biologic treatments for asthma, drugs which target
specific etiological pathways in particular asthma cases, have begun to emerge in the market as the first
individualized treatments for severe asthma. Cost of these biologics currently ranges from $10-$40k per year
and does not always improve asthma symptoms in some patients. The clinical decision to keep a patient on
a particular biologic is based on exacerbation count and asthma questionnaire responses at 12 weeks
following treatment initiation, by which time the patient has had 3 doses (at 0 weeks, 4 weeks, and 8 weeks).
Exacerbation count and patient responses to questionnaires were the primary endpoints of the clinical trials
which resulted in approval and are the primary biomarkers used in clinical evaluation of response, but patient-
specific biomarkers of lung function would be most beneficial for evaluation of response to these patient-
specific drugs. The lack of biomarkers which can predict response to biologic treatment is an unmet clinical
need. This study will address this unmet need by evaluating the potential of hyperpolarized 129Xe MRI (HPG)
to detect and predict biologic response in individual patients. Hyperpolarization is the process by which the
nuclear magnetism of 129Xe is greatly enhanced allowing it to be directly imaged by MRI. Subjects inhale the
xenon gas, and MRI are collected yielding high-resolution maps of regional lung ventilation. The overarching
hypothesis is that HPG MR can be performed in a routine clinical setting and will predict which patients
respond to treatment with mepolizumab, an anti-IL-5 biologic, 8 to 12 weeks sooner than standard clinical
assessment. HPG MRI will be performed in asthma patients slated to receive treatment by mepolizumab at
baseline, 4-week, and 12-week time points in order to assess its potential to assess, detect, and predict
patient response to mepolizumab. This may dramatically reduce costs and improve outcomes for these
patients.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Robert Paul Thomen其他文献
Robert Paul Thomen的其他文献
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{{ truncateString('Robert Paul Thomen', 18)}}的其他基金
Hyperpolarized xenon MRI in treatment of severe asthma by mepolizumab: toward earlier detection of individual patient responses
美泊利单抗治疗严重哮喘的超极化氙 MRI:早期检测个体患者的反应
- 批准号:
10652986 - 财政年份:2020
- 资助金额:
$ 38.75万 - 项目类别:
Hyperpolarized xenon MRI in treatment of severe asthma by mepolizumab: toward earlier detection of individual patient responses
美泊利单抗治疗严重哮喘的超极化氙 MRI:早期检测个体患者的反应
- 批准号:
10171901 - 财政年份:2020
- 资助金额:
$ 38.75万 - 项目类别:
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