ID

14359

Descripción

SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII); ODM derived from: https://clinicaltrials.gov/show/NCT00455923

Link

https://clinicaltrials.gov/show/NCT00455923

Palabras clave

Versiones (1)
  1. 12/4/16 12/4/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

12 de abril de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00455923

Inglés

Eligibility Asthma NCT00455923

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00455923
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing to give informed consent.
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
males or females aged 18-70.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and complete dairy cards.
Descripción

able to understand and complete dairy cards

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 >80% predicted 4. pc20 <8mg/ml
Descripción

mild persistent asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960046
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1714620
UMLS CUI [4,1]
C1276804
UMLS CUI [4,2]
C0436350
UMLS CUI [5,1]
C2957235
UMLS CUI [5,2]
C0436350
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
change to regular asthma medication in 4-weeks prior to visit 1.
Descripción

asthma medication change

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0580105
UMLS CUI [1,4]
C0040223
use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
Descripción

corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0040223
lower respiratory tract within 4 weeks of visit 1
Descripción

lower respiratory tract infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149725
received investigational study drug within 4 weeks of visit
Descripción

investigational drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
smoking history of >10 pack years of more.
Descripción

smoking history

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
serious uncontrolled disease.
Descripción

serious uncontrolled disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
medical conditions or medications known to affect the assessments or endpoints.
Descripción

comorbidity limiting study protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
evidence of alcohol or drug abuse.
Descripción

alcohol or drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
known pregnancy or planned pregnancy.
Descripción

pregnancy or planned pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1283828
known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
Descripción

hypersensitivity to inhaled corticosteroids, beta-agonists or lactose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2065041
UMLS CUI [1,3]
C0001644
UMLS CUI [1,4]
C0022949
previous enrollment in the study
Descripción

previous enrollment in the study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT00455923

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00455923
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
age
Item
males or females aged 18-70.
boolean
C0001779 (UMLS CUI [1])
able to understand and complete dairy cards
Item
able to understand and complete dairy cards.
boolean
C1321605 (UMLS CUI [1])
mild persistent asthma
Item
mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 >80% predicted 4. pc20 <8mg/ml
boolean
C1960046 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1714620 (UMLS CUI [3])
C1276804 (UMLS CUI [4,1])
C0436350 (UMLS CUI [4,2])
C2957235 (UMLS CUI [5,1])
C0436350 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
asthma medication change
Item
change to regular asthma medication in 4-weeks prior to visit 1.
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
corticosteroids
Item
use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
boolean
C0001617 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
lower respiratory tract infection
Item
lower respiratory tract within 4 weeks of visit 1
boolean
C0149725 (UMLS CUI [1])
investigational drug
Item
received investigational study drug within 4 weeks of visit
boolean
C0013230 (UMLS CUI [1])
smoking history
Item
smoking history of >10 pack years of more.
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
serious uncontrolled disease
Item
serious uncontrolled disease.
boolean
C0009488 (UMLS CUI [1])
comorbidity limiting study protocol
Item
medical conditions or medications known to affect the assessments or endpoints.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
alcohol or drug abuse
Item
evidence of alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
pregnancy or planned pregnancy
Item
known pregnancy or planned pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
hypersensitivity to inhaled corticosteroids, beta-agonists or lactose
Item
known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
boolean
C0020517 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0001644 (UMLS CUI [1,3])
C0022949 (UMLS CUI [1,4])
previous enrollment in the study
Item
previous enrollment in the study
boolean
C2348568 (UMLS CUI [1])
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