ID

14340

Beschrijving

Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT00392288

Link

https://clinicaltrials.gov/show/NCT00392288

Trefwoorden

Versies (1)
  1. 11-04-16 11-04-16 -
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CC BY-NC 3.0

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11 april 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00392288

Engels

Eligibility Asthma NCT00392288

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00392288
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of persistent bronchial asthma for at least 3 months prior to screening;
Beschrijving

persistent asthma

Datatype

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0040223
for patients with persistent bronchial asthma and being treated with a controller therapy: documented use of an inhaled steroid or singulair® 5mg once daily;
Beschrijving

inhaled steroid or singulair

Datatype

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0595724
for patients with persistent bronchial asthma and not being treated with controller therapy: patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
Beschrijving

albuterol/salbutamol

Datatype

boolean

Alias
UMLS CUI [1]
C0001927
morning peak expiratory flow (am pef) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
Beschrijving

am pef

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030735
UMLS CUI [1,2]
C0332170
UMLS CUI [2]
C0001927
only patients aged between 6 to <12 years must have a forced expiratory volume in one second (fev1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol
Beschrijving

fev1

Datatype

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0001927
UMLS CUI [3]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
Beschrijving

nocturnal awakenings

Datatype

boolean

Alias
UMLS CUI [1]
C0860510
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0001927
use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
Beschrijving

more than 8 puffs/day of albuterol/salbutamol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001927
UMLS CUI [1,2]
C3476109
upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
Beschrijving

respiratory tract infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
history of life-threatening asthma, including a history of significant hypercarbia (pco2 >45 mmhg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
Beschrijving

life-threatening asthma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0020440
UMLS CUI [3]
C0021925
UMLS CUI [4]
C0349790
UMLS CUI [5]
C0162297
more than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
Beschrijving

hospitalization or emergency care

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0349790
UMLS CUI [3]
C1527398
use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
Beschrijving

corticosteroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0040223
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Similar models

Eligibility Asthma NCT00392288

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00392288
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
persistent asthma
Item
history of persistent bronchial asthma for at least 3 months prior to screening;
boolean
C3266628 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
inhaled steroid or singulair
Item
for patients with persistent bronchial asthma and being treated with a controller therapy: documented use of an inhaled steroid or singulair® 5mg once daily;
boolean
C2065041 (UMLS CUI [1])
C0595724 (UMLS CUI [2])
albuterol/salbutamol
Item
for patients with persistent bronchial asthma and not being treated with controller therapy: patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
boolean
C0001927 (UMLS CUI [1])
am pef
Item
morning peak expiratory flow (am pef) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
boolean
C0030735 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C0001927 (UMLS CUI [2])
fev1
Item
only patients aged between 6 to <12 years must have a forced expiratory volume in one second (fev1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol
boolean
C0748133 (UMLS CUI [1])
C0001927 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
nocturnal awakenings
Item
nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
boolean
C0860510 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0001927 (UMLS CUI [3])
more than 8 puffs/day of albuterol/salbutamol
Item
use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
boolean
C0001927 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
respiratory tract infection
Item
upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
life-threatening asthma
Item
history of life-threatening asthma, including a history of significant hypercarbia (pco2 >45 mmhg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0020440 (UMLS CUI [2])
C0021925 (UMLS CUI [3])
C0349790 (UMLS CUI [4])
C0162297 (UMLS CUI [5])
hospitalization or emergency care
Item
more than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
boolean
C0019993 (UMLS CUI [1])
C0349790 (UMLS CUI [2])
C1527398 (UMLS CUI [3])
corticosteroids
Item
use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
boolean
C0001617 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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