ID

14389

Beschrijving

Bronchoscopy With Bronchial Biopsies Sub-study of: Persistence of Airway Inflammation and Remodeling in Asthma Remission; ODM derived from: https://clinicaltrials.gov/show/NCT00526344

Link

https://clinicaltrials.gov/show/NCT00526344

Trefwoorden

Versies (1)
  1. 13-04-16 13-04-16 -
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CC BY-NC 3.0

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13 april 2016

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00526344

Engels

Eligibility Asthma NCT00526344

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00526344
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
in remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (fev1 > 90%) and normal pc20 methacholine for more than two years (with no current treatment).
Beschrijving

asthma remission

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0544452
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0430567
UMLS CUI [4,1]
C0004096
UMLS CUI [4,2]
C1457887
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0004096
UMLS CUI [6]
C0040223
with a proven past history of asthma from medical files (reversible airway obstruction (> 12% fev1 after bronchodilator or 20% by other means) proven by spirometry, pef measures or methacholine challenge according to current criteria +
Beschrijving

asthma history

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0748133
UMLS CUI [2,2]
C2599594
UMLS CUI [3]
C0037981
UMLS CUI [4]
C0030735
UMLS CUI [5]
C0430567
previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
Beschrijving

asthma symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0004096
UMLS CUI [3]
C0040223
agree to sign the consent form.
Beschrijving

consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
no other condition that could interfere with the study measurements.
Beschrijving

comorbidity limiting study protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects using inhaled or oral anti-inflammatory agents.
Beschrijving

inhaled or oral anti-inflammatory agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003209
UMLS CUI [1,2]
C0001559
UMLS CUI [1,3]
C0442027
fev1 < 1.2 l.
Beschrijving

fev1

Datatype

boolean

Alias
UMLS CUI [1]
C0748133
unable to adhere to the protocol requirements.
Beschrijving

unable to adhere to the protocol requirements

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
other current respiratory disease
Beschrijving

respiratory disease

Datatype

boolean

Alias
UMLS CUI [1]
C0035204
upper or lower respiratory tract infection or use of antibiotics < 1 month.
Beschrijving

respiratory tract infection or use of antibiotics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C0040223
use of oral corticosteroids within the last 3 months.
Beschrijving

oral corticosteroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0040223
signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Asthma NCT00526344

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00526344
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
asthma remission
Item
in remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (fev1 > 90%) and normal pc20 methacholine for more than two years (with no current treatment).
boolean
C0004096 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C0430567 (UMLS CUI [3])
C0004096 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5,1])
C0004096 (UMLS CUI [5,2])
C0040223 (UMLS CUI [6])
asthma history
Item
with a proven past history of asthma from medical files (reversible airway obstruction (> 12% fev1 after bronchodilator or 20% by other means) proven by spirometry, pef measures or methacholine challenge according to current criteria +
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2,1])
C2599594 (UMLS CUI [2,2])
C0037981 (UMLS CUI [3])
C0030735 (UMLS CUI [4])
C0430567 (UMLS CUI [5])
asthma symptoms
Item
previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0040223 (UMLS CUI [3])
consent
Item
agree to sign the consent form.
boolean
C0021430 (UMLS CUI [1])
comorbidity limiting study protocol
Item
no other condition that could interfere with the study measurements.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
inhaled or oral anti-inflammatory agents
Item
subjects using inhaled or oral anti-inflammatory agents.
boolean
C0003209 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0442027 (UMLS CUI [1,3])
fev1
Item
fev1 < 1.2 l.
boolean
C0748133 (UMLS CUI [1])
unable to adhere to the protocol requirements
Item
unable to adhere to the protocol requirements.
boolean
C1321605 (UMLS CUI [1])
respiratory disease
Item
other current respiratory disease
boolean
C0035204 (UMLS CUI [1])
respiratory tract infection or use of antibiotics
Item
upper or lower respiratory tract infection or use of antibiotics < 1 month.
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
oral corticosteroids
Item
use of oral corticosteroids within the last 3 months.
boolean
C0001617 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
comorbidity
Item
signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
boolean
C0009488 (UMLS CUI [1])
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