ID

14368

Description

Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00504062

Lien

https://clinicaltrials.gov/show/NCT00504062

Mots-clés

Versions (1)
  1. 12/04/2016 12/04/2016 -
Détendeur de droits

CC BY-NC 3.0

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12 avril 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00504062

Anglais

Eligibility Asthma NCT00504062

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00504062
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves
Description

written informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic
Description

bronchial asthma

Type de données

boolean

Alias
UMLS CUI [1]
C0004096
males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "turbuhaler trainer"
Description

age compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1553479
UMLS CUI [2,2]
C1321605
UMLS CUI [3,1]
C1553480
UMLS CUI [3,2]
C1321605
patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled)
Description

inhaled steroids

Type de données

boolean

Alias
UMLS CUI [1]
C2065041
patients who are already treated with inhaled gcs should have at least 3 months prehistory of asthma before obtaining the written informed consent
Description

patients who are already treated with inhaled gcs should have at least 3 months prehistory of asthma

Type de données

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0040223
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period
Description

systemic steroids

Type de données

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0040223
the daily dose of inhaled gcs within 30 days before the observation period for the patients who are already treated with inhaled gcs is beyond fluticasone propionate (fp) 200 µg/day or beclomethasone dipropionate (bdp) 200 μg/day.
Description

fluticasone propionate or beclomethasone dipropionate

Type de données

boolean

Alias
UMLS CUI [1]
C0117996
UMLS CUI [2]
C0004906
respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g. lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis within 30 days before the observation period.
Description

respiratory infection

Type de données

boolean

Alias
UMLS CUI [1]
C0035243
concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
Description

comorbidity limiting study protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product
Description

contraindications

Type de données

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0054201
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0082607
UMLS CUI [3,1]
C0522473
UMLS CUI [3,2]
C0022949
participation in another clinical study within 12 weeks prior to the observation period or during the study
Description

participation in another clinical study

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0040223
previous enrolment in the present study
Description

previous enrolment in the present study

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
current use of budesonide turbuhaler
Description

budesonide turbuhaler

Type de données

boolean

pregnancy or possible pregnancy, or planning to be pregnant during the study period
Description

pregnancy or intention to become pregnant

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1283828
patients whose legal representative/caregiver is involved in the planning and conduct of the study (applies to both astrazeneca staff or staff at the study site)
Description

patients whose legal representative/caregiver is involved in the planning and conduct of the study

Type de données

boolean

Alias
UMLS CUI [1]
C0599987
UMLS CUI [2]
C0205210
UMLS CUI [3]
C0683939
UMLS CUI [4]
C1314939
UMLS CUI [5]
C0008976
UMLS CUI [6]
C0086282
other subjects who are considered inappropriate to participate in this study as judged by the investigator
Description

ineligibility

Type de données

boolean

Alias
UMLS CUI [1]
C1512714
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Similar models

Eligibility Asthma NCT00504062

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00504062
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves
boolean
C0021430 (UMLS CUI [1])
bronchial asthma
Item
patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic
boolean
C0004096 (UMLS CUI [1])
age compliance
Item
males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "turbuhaler trainer"
boolean
C0001779 (UMLS CUI [1])
C1553479 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1553480 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
inhaled steroids
Item
patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled)
boolean
C2065041 (UMLS CUI [1])
patients who are already treated with inhaled gcs should have at least 3 months prehistory of asthma
Item
patients who are already treated with inhaled gcs should have at least 3 months prehistory of asthma before obtaining the written informed consent
boolean
C2065041 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
systemic steroids
Item
use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period
boolean
C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
fluticasone propionate or beclomethasone dipropionate
Item
the daily dose of inhaled gcs within 30 days before the observation period for the patients who are already treated with inhaled gcs is beyond fluticasone propionate (fp) 200 µg/day or beclomethasone dipropionate (bdp) 200 μg/day.
boolean
C0117996 (UMLS CUI [1])
C0004906 (UMLS CUI [2])
respiratory infection
Item
respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g. lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis within 30 days before the observation period.
boolean
C0035243 (UMLS CUI [1])
comorbidity limiting study protocol
Item
concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
contraindications
Item
contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product
boolean
C0522473 (UMLS CUI [1,1])
C0054201 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0082607 (UMLS CUI [2,2])
C0522473 (UMLS CUI [3,1])
C0022949 (UMLS CUI [3,2])
participation in another clinical study
Item
participation in another clinical study within 12 weeks prior to the observation period or during the study
boolean
C2348568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
previous enrolment in the present study
Item
previous enrolment in the present study
boolean
C2348568 (UMLS CUI [1])
budesonide turbuhaler
Item
current use of budesonide turbuhaler
boolean
pregnancy or intention to become pregnant
Item
pregnancy or possible pregnancy, or planning to be pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
patients whose legal representative/caregiver is involved in the planning and conduct of the study
Item
patients whose legal representative/caregiver is involved in the planning and conduct of the study (applies to both astrazeneca staff or staff at the study site)
boolean
C0599987 (UMLS CUI [1])
C0205210 (UMLS CUI [2])
C0683939 (UMLS CUI [3])
C1314939 (UMLS CUI [4])
C0008976 (UMLS CUI [5])
C0086282 (UMLS CUI [6])
ineligibility
Item
other subjects who are considered inappropriate to participate in this study as judged by the investigator
boolean
C1512714 (UMLS CUI [1])
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