ID

14291

Descripción

Control of Asthma Patients Symptomatic on Inhaled Corticosteroids; ODM derived from: https://clinicaltrials.gov/show/NCT00330070

Link

https://clinicaltrials.gov/show/NCT00330070

Palabras clave

  1. 7/4/16 7/4/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

7 de abril de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00330070

Eligibility Asthma NCT00330070

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00330070
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a history of persistent asthma for at least the 4 months prior to entry
Descripción

persistent asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3266628
require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (saba)
Descripción

inhaled corticosteroids and saba

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2917450
fev1 at randomization (without exposure to a saba for at least 6 hours) must be between 50% and 80% of predicted normal
Descripción

fev1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748133
reversibility of fev1 by at least 12% and at least 250 ml following two to four inhalations of a saba must be demonstrated prior to randomization
Descripción

reversibility of fev1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0679253
UMLS CUI [1,3]
C2917450
aqlq(s) score of 4.5 or less at both the screening (visit 1) and randomization (visit 2) visits
Descripción

AQLQ

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2919855
patients must meet at least two out of three of the following criteria:
Descripción

criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512693
overall score minimum of 2 on asthma control questionnaire (acq)
Descripción

asthma control questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2919686
require rescue saba use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period
Descripción

saba use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1373132
nighttime awakenings due to asthma, an average of at least once a week during the baseline period
Descripción

nighttime awakenings due to asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1273489
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (copd), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis
Descripción

copd or other relevant lung diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0024115
other asthma therapies:
Descripción

asthma therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
use of long-acting beta-2-agonists within 5 weeks prior to randomization
Descripción

beta-2 agonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1373132
use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization
Descripción

leukotriene, theophylline, or muscarinic antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3542962
UMLS CUI [2]
C0039771
UMLS CUI [3]
C0003385
use of injectable or oral corticosteroids within 2 months prior to screening
Descripción

corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0040223
requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period
Descripción

beta 2 agonist frequency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2936789
UMLS CUI [1,2]
C3476109

Similar models

Eligibility Asthma NCT00330070

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00330070
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
persistent asthma
Item
a history of persistent asthma for at least the 4 months prior to entry
boolean
C3266628 (UMLS CUI [1])
inhaled corticosteroids and saba
Item
require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (saba)
boolean
C2065041 (UMLS CUI [1])
C2917450 (UMLS CUI [2])
fev1
Item
fev1 at randomization (without exposure to a saba for at least 6 hours) must be between 50% and 80% of predicted normal
boolean
C0748133 (UMLS CUI [1])
reversibility of fev1
Item
reversibility of fev1 by at least 12% and at least 250 ml following two to four inhalations of a saba must be demonstrated prior to randomization
boolean
C0748133 (UMLS CUI [1,1])
C0679253 (UMLS CUI [1,2])
C2917450 (UMLS CUI [1,3])
AQLQ
Item
aqlq(s) score of 4.5 or less at both the screening (visit 1) and randomization (visit 2) visits
boolean
C2919855 (UMLS CUI [1])
criteria
Item
patients must meet at least two out of three of the following criteria:
boolean
C1512693 (UMLS CUI [1])
asthma control questionnaire
Item
overall score minimum of 2 on asthma control questionnaire (acq)
boolean
C2919686 (UMLS CUI [1])
saba use
Item
require rescue saba use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period
boolean
C1373132 (UMLS CUI [1])
nighttime awakenings due to asthma
Item
nighttime awakenings due to asthma, an average of at least once a week during the baseline period
boolean
C1273489 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
copd or other relevant lung diseases
Item
history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (copd), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
asthma therapy
Item
other asthma therapies:
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
beta-2 agonists
Item
use of long-acting beta-2-agonists within 5 weeks prior to randomization
boolean
C1373132 (UMLS CUI [1])
leukotriene, theophylline, or muscarinic antagonists
Item
use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization
boolean
C3542962 (UMLS CUI [1])
C0039771 (UMLS CUI [2])
C0003385 (UMLS CUI [3])
corticosteroids
Item
use of injectable or oral corticosteroids within 2 months prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
beta 2 agonist frequency
Item
requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period
boolean
C2936789 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

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