ID

14273

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00231114

Nyckelord

Versioner (1)
  1. 2016-04-07 2016-04-07 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

7 april 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00231114

Engelsk

Eligibility Asthma NCT00231114

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00231114
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

age

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

pre-bronchodilator fev1

Datatyp

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.
Beskrivning

pc20

Datatyp

boolean

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

asthma symptom frequency

Datatyp

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).
Beskrivning

smoking history

Datatyp

boolean

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

Exclusion Criteria

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

post-bronchodilator fev1

Datatyp

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.
Beskrivning

hospitalizations for exacerbations of asthma

Datatyp

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).
Beskrivning

recurrent lower respiratory tract infections

Datatyp

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).
Beskrivning

recurrent oral steroid use

Datatyp

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).
Beskrivning

sensitivity to medications required to perform bronchoscopy

Datatyp

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.
Beskrivning

hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents

Datatyp

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.
Beskrivning

other medical criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Asthma NCT00231114

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00231114
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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