Informações:
Falhas:
ID
36838
Descrição
Study of the Prednisone Sparing Effect of Xolair (Omalizumab) in Patients With Prednisone-dependent Asthma With Eosinophilic Bronchitis; ODM derived from: https://clinicaltrials.gov/show/NCT02049294
Link
https://clinicaltrials.gov/show/NCT02049294
Palavras-chave
Versões (1)
- 14/06/2019 14/06/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
14 de junho de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Prednisone Dependent Asthma NCT02049294
Eligibility Prednisone Dependent Asthma NCT02049294
- StudyEvent: Eligibility
Similar models
Eligibility Prednisone Dependent Asthma NCT02049294
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Asthma | Reversibility Bronchodilator Percentage | Methacholine
Item
confirmed asthma within the past 2 years (12% bronchodilator reversibility or pc20 methacholine less than 8 mg/ml)
boolean
C0004096 (UMLS CUI [1])
C0449261 (UMLS CUI [2,1])
C0006280 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0600370 (UMLS CUI [3])
C0449261 (UMLS CUI [2,1])
C0006280 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0600370 (UMLS CUI [3])
Sputum eosinophils
Item
sputum eosinophils greater than 3% on at least 2 occasions
boolean
C2019288 (UMLS CUI [1])
Asthma control questionnaire | Sputum eosinophils
Item
asthma control questionnaire (acq) <1.5 and sputum eos <3% at the time of randomization (ie. optimal steroid dose)
boolean
C2919686 (UMLS CUI [1])
C2019288 (UMLS CUI [2])
C2019288 (UMLS CUI [2])
Adrenal Cortex Hormones by Inhalation | Adrenergic beta-Agonists Active Long-term
Item
on inhaled corticosteroids (ics) and long acting beta agonist (laba) (irrespective of dose)
boolean
C0001617 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0001644 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C0205535 (UMLS CUI [1,2])
C0001644 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
Serum IgE measurement
Item
total serum ige >120 iu/l
boolean
C2229760 (UMLS CUI [1])
Age
Item
age between 18 and 75 years
boolean
C0001779 (UMLS CUI [1])
Tobacco use | Former smoker Pack years Quantity
Item
current smoker or ex-smokers with greater than 20 pack years
boolean
C0543414 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0337671 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Comorbidity | Study Subject Participation Status Inappropriate
Item
co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study
boolean
C0009488 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
omalizumab
Item
currently on omalizumab or has previously been treated with omalizumab
boolean
C0966225 (UMLS CUI [1])
Biological treatment
Item
currently on other biologic therapies
boolean
C1531518 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Percent predicted FEV1 post bronchodilator
Item
post bronchodilator fev1 less than 50% predicted
boolean
C0730561 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C2599594 (UMLS CUI [1,2])