Information:
Fel:
ID
14340
Beskrivning
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT00392288
Länk
https://clinicaltrials.gov/show/NCT00392288
Nyckelord
Versioner (1)
- 2016-04-11 2016-04-11 -
Rättsinnehavare
CC BY-NC 3.0
Uppladdad den
11 april 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00392288
Eligibility Asthma NCT00392288
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT00392288
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
C0001927 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
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])
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])
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])
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])
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])
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])
C0040223 (UMLS CUI [1,2])