ID

14188

Beskrivning

Effect of Symbicort on GR Localisation in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00159263

Länk

https://clinicaltrials.gov/show/NCT00159263

Nyckelord

Versioner (1)
  1. 2016-04-04 2016-04-04 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

4 april 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00159263

Engelsk

Eligibility Asthma NCT00159263

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00159263
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with mild steroid-naïve asthma (ats criteria) of either sex with fev1 >70 % pred
Beskrivning

steroid-naïve asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0038317
UMLS CUI [1,3]
C0919936
UMLS CUI [2]
C0748133
able to produce sputum after sputum induction
Beskrivning

sputum

Datatyp

boolean

Alias
UMLS CUI [1]
C0038056
exhaled no (flow 50 ml/s) ≥ 20 ppb
Beskrivning

exhaled no

Datatyp

boolean

written informed consent
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current upper respiratory tract infections
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
use of inhaled and/or oral gcs within 4 weeks prior to visit 1
Beskrivning

steroid

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
Beskrivning

antileukotrienes, theophylline, tiotropium and ipratropium

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039771
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1306772
UMLS CUI [2,2]
C0040223
UMLS CUI [3,1]
C0700580
UMLS CUI [3,2]
C0040223
hypersensitivity to any of the investigational drugs or lactose
Beskrivning

hypersensitivity to any of the investigational drugs or lactose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022949
use of any -blocking agent (including eye-drops)
Beskrivning

use of any -blocking agent (including eye-drops)

Datatyp

boolean

women who are pregnant, breast-feeding or planning a pregnancy during the study. women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
Beskrivning

pregnancy, lactation, contraception, postmenopausal

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0232970
any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
Beskrivning

comorbidity limiting study participation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
inability to tolerate temporary withdrawal of bronchodilatory therapy
Beskrivning

inability to tolerate temporary withdrawal of bronchodilatory therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006280
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0231197
subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
Beskrivning

comorbidity limiting compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
previous randomization in this study
Beskrivning

previous randomization in this study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0205156
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Similar models

Eligibility Asthma NCT00159263

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00159263
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
steroid-naïve asthma
Item
patients with mild steroid-naïve asthma (ats criteria) of either sex with fev1 >70 % pred
boolean
C0004096 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0748133 (UMLS CUI [2])
sputum
Item
able to produce sputum after sputum induction
boolean
C0038056 (UMLS CUI [1])
exhaled no
Item
exhaled no (flow 50 ml/s) ≥ 20 ppb
boolean
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
current upper respiratory tract infections
boolean
C0009488 (UMLS CUI [1])
steroid
Item
use of inhaled and/or oral gcs within 4 weeks prior to visit 1
boolean
C0038317 (UMLS CUI [1])
antileukotrienes, theophylline, tiotropium and ipratropium
Item
treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
boolean
C0039771 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1306772 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0700580 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
hypersensitivity to any of the investigational drugs or lactose
Item
hypersensitivity to any of the investigational drugs or lactose
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0022949 (UMLS CUI [2,2])
use of any -blocking agent (including eye-drops)
Item
use of any -blocking agent (including eye-drops)
boolean
pregnancy, lactation, contraception, postmenopausal
Item
women who are pregnant, breast-feeding or planning a pregnancy during the study. women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
comorbidity limiting study participation
Item
any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
inability to tolerate temporary withdrawal of bronchodilatory therapy
Item
inability to tolerate temporary withdrawal of bronchodilatory therapy
boolean
C0006280 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0231197 (UMLS CUI [1,3])
comorbidity limiting compliance
Item
subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
previous randomization in this study
Item
previous randomization in this study
boolean
C0034656 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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