ID

14273

Descrição

Asthma Intervention Research 2 (AIR2) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00231114

Link

https://clinicaltrials.gov/show/NCT00231114

Palavras-chave

Versões (1)
  1. 07/04/2016 07/04/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

7 de abril de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00231114

Inglês

Eligibility Asthma NCT00231114

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00231114
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is an adult between the ages of 18 to 65 years.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba).
Descrição

asthma, inhaled corticosteroid (ics) and long acting ß2-agonist (laba)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C3248292
UMLS CUI [3,1]
C2936789
UMLS CUI [3,2]
C0040223
subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period.
Descrição

pre-bronchodilator fev1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3172227
subject has a pc20 < 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline.
Descrição

pc20

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1714620
subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period.
Descrição

asthma symptom frequency

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0439603
subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
Descrição

smoking history

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a post-bronchodilator fev1 of less than 65%.
Descrição

post-bronchodilator fev1

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months.
Descrição

hospitalizations for exacerbations of asthma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0349790
UMLS CUI [3,1]
C0004096
UMLS CUI [3,2]
C2826244
subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
Descrição

recurrent lower respiratory tract infections

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0149725
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
Descrição

recurrent oral steroid use

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0574135
UMLS CUI [1,2]
C2945760
subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
Descrição

sensitivity to medications required to perform bronchoscopy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023660
UMLS CUI [1,3]
C0004259
UMLS CUI [1,4]
C0005064
subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents.
Descrição

hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079829
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0030512
subject has other medical criteria.
Descrição

other medical criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Asthma NCT00231114

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00231114
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
subject is an adult between the ages of 18 to 65 years.
boolean
C0001779 (UMLS CUI [1])
asthma, inhaled corticosteroid (ics) and long acting ß2-agonist (laba)
Item
subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba).
boolean
C0004096 (UMLS CUI [1])
C3248292 (UMLS CUI [2])
C2936789 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
pre-bronchodilator fev1
Item
subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period.
boolean
C3172227 (UMLS CUI [1])
pc20
Item
subject has a pc20 < 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline.
boolean
C1714620 (UMLS CUI [1])
asthma symptom frequency
Item
subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period.
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
smoking history
Item
subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
post-bronchodilator fev1
Item
subject has a post-bronchodilator fev1 of less than 65%.
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
hospitalizations for exacerbations of asthma
Item
subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months.
boolean
C0019993 (UMLS CUI [1])
C0349790 (UMLS CUI [2])
C0004096 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
recurrent lower respiratory tract infections
Item
subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
boolean
C0149725 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
recurrent oral steroid use
Item
subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
boolean
C0574135 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
sensitivity to medications required to perform bronchoscopy
Item
subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
boolean
C0020517 (UMLS CUI [1,1])
C0023660 (UMLS CUI [1,2])
C0004259 (UMLS CUI [1,3])
C0005064 (UMLS CUI [1,4])
hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
Item
subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents.
boolean
C0020517 (UMLS CUI [1,1])
C0079829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0030512 (UMLS CUI [2,2])
other medical criteria
Item
subject has other medical criteria.
boolean
C0009488 (UMLS CUI [1])
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