ID

14365

Description

Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00490243

Link

https://clinicaltrials.gov/show/NCT00490243

Keywords

  1. 4/12/16 4/12/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 12, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00490243

Eligibility Asthma NCT00490243

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00490243
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients
Description

outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
aged 6 to 18 with a clinical diagnosis of bronchial asthma with a duration of at least 6 months before the first visit and with current history of moderate persistent asthma
Description

age and asthma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0004096
UMLS CUI [3]
C1960047
sensitive to house dust mites as shown by positive skin-prick tests to dermatophagoides pteronyssinus or dermatophagoides farinae
Description

sensitive to house dust mites

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3539110
UMLS CUI [2]
C0430561
to become eligible for the active treatment period, patients and their parents were required to do reproducible spirometry, whole body plethysmography and interrupter technique.
Description

spirometry, whole body plethysmography and interrupter technique

Data type

boolean

Alias
UMLS CUI [1]
C0037981
UMLS CUI [2]
C0032224
in order to be included in the study the patients had to have a resting fev1 of more or equal 70%.
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
study exclusions included:
Description

exclusion

Data type

boolean

Alias
UMLS CUI [1]
C2828389
active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
Description

respiratory tract infection and acute sinus disease requiring antibiotic treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0037199
UMLS CUI [3]
C0003232
previous intubation
Description

intubation

Data type

boolean

Alias
UMLS CUI [1]
C0021925
asthma hospitalisation during the 3 months before the first visit.
Description

asthma hospitalisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
Description

comorbidity limiting study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
excluded medications were β-blockers (eye drops included), astemizole within 3 months, or oral corticosteroids within 1 month before the first visit.
Description

beta-blockers, astamizole, oral corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2]
C0001617
patients who were receiving immunotherapy were also excluded.
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0021083

Similar models

Eligibility Asthma NCT00490243

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00490243
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
outpatients
Item
male and female outpatients
boolean
C0029921 (UMLS CUI [1])
age and asthma
Item
aged 6 to 18 with a clinical diagnosis of bronchial asthma with a duration of at least 6 months before the first visit and with current history of moderate persistent asthma
boolean
C0001779 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C1960047 (UMLS CUI [3])
sensitive to house dust mites
Item
sensitive to house dust mites as shown by positive skin-prick tests to dermatophagoides pteronyssinus or dermatophagoides farinae
boolean
C0020517 (UMLS CUI [1,1])
C3539110 (UMLS CUI [1,2])
C0430561 (UMLS CUI [2])
spirometry, whole body plethysmography and interrupter technique
Item
to become eligible for the active treatment period, patients and their parents were required to do reproducible spirometry, whole body plethysmography and interrupter technique.
boolean
C0037981 (UMLS CUI [1])
C0032224 (UMLS CUI [2])
fev1
Item
in order to be included in the study the patients had to have a resting fev1 of more or equal 70%.
boolean
C0748133 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion
Item
study exclusions included:
boolean
C2828389 (UMLS CUI [1])
respiratory tract infection and acute sinus disease requiring antibiotic treatment
Item
active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0037199 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
intubation
Item
previous intubation
boolean
C0021925 (UMLS CUI [1])
asthma hospitalisation
Item
asthma hospitalisation during the 3 months before the first visit.
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
comorbidity limiting study protocol
Item
additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
beta-blockers, astamizole, oral corticosteroids
Item
excluded medications were β-blockers (eye drops included), astemizole within 3 months, or oral corticosteroids within 1 month before the first visit.
boolean
C0304516 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
immunotherapy
Item
patients who were receiving immunotherapy were also excluded.
boolean
C0021083 (UMLS CUI [1])

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