ID

14274

Beschrijving

A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00252135

Link

https://clinicaltrials.gov/show/NCT00252135

Trefwoorden

Versies (1)
  1. 07-04-16 07-04-16 -
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CC BY-NC 3.0

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7 april 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00252135

Engels

Eligibility Asthma NCT00252135

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00252135
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
≥12 years of age
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
physician diagnosis of moderate to severe persistent asthma
Beschrijving

moderate to severe persistent asthma

Datatype

boolean

Alias
UMLS CUI [1]
C1960047
UMLS CUI [2]
C1960048
evidence or history of positive skin test or in vitro reactivity to an aeroallergen
Beschrijving

positive skin test or in vitro reactivity to an aeroallergen

Datatype

boolean

Alias
UMLS CUI [1]
C0037296
UMLS CUI [2]
C0001697
willingness to participate fully for the duration of the study (5 years)
Beschrijving

willingness to participate fully for the duration of the study

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
for patients in the xolair-treated cohort, have received at least one dose of xolair therapy at the time of enrollment
Beschrijving

xolair therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1174773
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication to xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to xolair)
Beschrijving

contraindication to xolair therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1174773
UMLS CUI [1,2]
C1301624
acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
Beschrijving

asthma exacerbation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C4039704
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0583237
UMLS CUI [5]
C0019993
acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0019993
use of an experimental drug within 30 days prior to study screening
Beschrijving

experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0040223
diagnosis of cystic fibrosis
Beschrijving

cystic fibrosis

Datatype

boolean

Alias
UMLS CUI [1]
C0010674
for patients in the non-xolair-treated cohort, any prior treatment with xolair
Beschrijving

prior treatment with xolair

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1174773
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Similar models

Eligibility Asthma NCT00252135

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00252135
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
boolean
C0021430 (UMLS CUI [1])
age
Item
≥12 years of age
boolean
C0001779 (UMLS CUI [1])
moderate to severe persistent asthma
Item
physician diagnosis of moderate to severe persistent asthma
boolean
C1960047 (UMLS CUI [1])
C1960048 (UMLS CUI [2])
positive skin test or in vitro reactivity to an aeroallergen
Item
evidence or history of positive skin test or in vitro reactivity to an aeroallergen
boolean
C0037296 (UMLS CUI [1])
C0001697 (UMLS CUI [2])
willingness to participate fully for the duration of the study
Item
willingness to participate fully for the duration of the study (5 years)
boolean
C1321605 (UMLS CUI [1])
xolair therapy
Item
for patients in the xolair-treated cohort, have received at least one dose of xolair therapy at the time of enrollment
boolean
C1174773 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
contraindication to xolair therapy
Item
contraindication to xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to xolair)
boolean
C1174773 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
asthma exacerbation
Item
acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C4039704 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0583237 (UMLS CUI [4])
C0019993 (UMLS CUI [5])
comorbidity
Item
acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
boolean
C0009488 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
experimental drug
Item
use of an experimental drug within 30 days prior to study screening
boolean
C1514463 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
cystic fibrosis
Item
diagnosis of cystic fibrosis
boolean
C0010674 (UMLS CUI [1])
prior treatment with xolair
Item
for patients in the non-xolair-treated cohort, any prior treatment with xolair
boolean
C1514463 (UMLS CUI [1,1])
C1174773 (UMLS CUI [1,2])
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