ID

36838

Description

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

Keywords

Versions (1)
  1. 6/14/19 6/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prednisone Dependent Asthma NCT02049294

English

Eligibility Prednisone Dependent Asthma NCT02049294

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed asthma within the past 2 years (12% bronchodilator reversibility or pc20 methacholine less than 8 mg/ml)
Description

Asthma | Reversibility Bronchodilator Percentage | Methacholine

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0449261
UMLS CUI [2,2]
C0006280
UMLS CUI [2,3]
C0439165
UMLS CUI [3]
C0600370
sputum eosinophils greater than 3% on at least 2 occasions
Description

Sputum eosinophils

Data type

boolean

Alias
UMLS CUI [1]
C2019288
asthma control questionnaire (acq) <1.5 and sputum eos <3% at the time of randomization (ie. optimal steroid dose)
Description

Asthma control questionnaire | Sputum eosinophils

Data type

boolean

Alias
UMLS CUI [1]
C2919686
UMLS CUI [2]
C2019288
on inhaled corticosteroids (ics) and long acting beta agonist (laba) (irrespective of dose)
Description

Adrenal Cortex Hormones by Inhalation | Adrenergic beta-Agonists Active Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205535
UMLS CUI [2,1]
C0001644
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0443252
total serum ige >120 iu/l
Description

Serum IgE measurement

Data type

boolean

Alias
UMLS CUI [1]
C2229760
age between 18 and 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current smoker or ex-smokers with greater than 20 pack years
Description

Tobacco use | Former smoker Pack years Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C1277691
UMLS CUI [2,3]
C1265611
co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study
Description

Comorbidity | Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
currently on omalizumab or has previously been treated with omalizumab
Description

omalizumab

Data type

boolean

Alias
UMLS CUI [1]
C0966225
currently on other biologic therapies
Description

Biological treatment

Data type

boolean

Alias
UMLS CUI [1]
C1531518
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
post bronchodilator fev1 less than 50% predicted
Description

Percent predicted FEV1 post bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0730561
UMLS CUI [1,2]
C2599594
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Similar models

Eligibility Prednisone Dependent Asthma NCT02049294

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
Percent predicted FEV1 post bronchodilator
Item
post bronchodilator fev1 less than 50% predicted
boolean
C0730561 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
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