ID

21239

Beschrijving

OC000459 Bronchial Allergen Challenge; ODM derived from: https://clinicaltrials.gov/show/NCT01056692

Link

https://clinicaltrials.gov/show/NCT01056692

Trefwoorden

  1. 16-04-17 16-04-17 -
Geüploaded op

16 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Bronchial Asthma NCT01056692

Eligibility Bronchial Asthma NCT01056692

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
Beschrijving

asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
fev1 >65% of predicted on at least two occasions at screening.
Beschrijving

fev1

Datatype

boolean

Alias
UMLS CUI [1]
C0748133
at the screening allergen challenge, a decrease in fev1 of ≥20% in the early asthmatic reaction and of ≥15% in the lar to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
Beschrijving

fev1 after allergen challenge

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006265
UMLS CUI [1,2]
C0748133
no steroid usage in the past 12 weeks.
Beschrijving

steroid usage

Datatype

boolean

Alias
UMLS CUI [1]
C0038317
testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
Beschrijving

skin prick challenge

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C0057489
UMLS CUI [1,3]
C0032385
UMLS CUI [1,4]
C0440419
non smokers for a minimum of 6 months; less than 10 pack year history.
Beschrijving

smoking, pack years

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C1277691
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
respiratory tract pathology other than allergic asthma.
Beschrijving

respiratory tract disease

Datatype

boolean

Alias
UMLS CUI [1]
C0035242
lower respiratory tract infection within 4 weeks prior to an allergen challenge.
Beschrijving

lower respiratory tract infection

Datatype

boolean

Alias
UMLS CUI [1]
C0149725
receipt of prescribed or otc medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
Beschrijving

medication other than paracetamol or short acting beta agonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0000970
UMLS CUI [1,3]
C0001644

Similar models

Eligibility Bronchial Asthma NCT01056692

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
asthma
Item
known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
boolean
C0004096 (UMLS CUI [1])
fev1
Item
fev1 >65% of predicted on at least two occasions at screening.
boolean
C0748133 (UMLS CUI [1])
fev1 after allergen challenge
Item
at the screening allergen challenge, a decrease in fev1 of ≥20% in the early asthmatic reaction and of ≥15% in the lar to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
boolean
C0006265 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
steroid usage
Item
no steroid usage in the past 12 weeks.
boolean
C0038317 (UMLS CUI [1])
skin prick challenge
Item
testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
boolean
C0430561 (UMLS CUI [1,1])
C0057489 (UMLS CUI [1,2])
C0032385 (UMLS CUI [1,3])
C0440419 (UMLS CUI [1,4])
smoking, pack years
Item
non smokers for a minimum of 6 months; less than 10 pack year history.
boolean
C0543414 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
respiratory tract disease
Item
respiratory tract pathology other than allergic asthma.
boolean
C0035242 (UMLS CUI [1])
lower respiratory tract infection
Item
lower respiratory tract infection within 4 weeks prior to an allergen challenge.
boolean
C0149725 (UMLS CUI [1])
medication other than paracetamol or short acting beta agonists
Item
receipt of prescribed or otc medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
boolean
C0013227 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C0001644 (UMLS CUI [1,3])

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