ID

42355

Beschrijving

Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02161107

Link

https://clinicaltrials.gov/show/NCT02161107

Trefwoorden

Versies (1)
  1. 22-06-21 22-06-21 -
Houder van rechten

Circassia Limited Adiga Life Sciences, Inc.

Geüploaded op

22 juni 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Seasonal Allergic Rhinitis NCT02161107

Engels

Eligibility Seasonal Allergic Rhinitis NCT02161107

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, aged 18-65 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
asthma treated by inhaled saba or inhaled saba plus low-medium dose ics in 6 weeks prior to randomisation.
Beschrijving

Asthma treated by inhaled SABA | Astma treated by inhaled SABA plus low dose-medium dose ICS

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C2917450
UMLS CUI [1,4]
C0443303
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0205535
UMLS CUI [2,3]
C2917450
UMLS CUI [2,4]
C0443303
UMLS CUI [2,5]
C0332287
UMLS CUI [2,6]
C2065041
UMLS CUI [2,7]
C0445550
UMLS CUI [2,8]
C0439536
a reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to grass for at least the previous two grass seasons.
Beschrijving

Reliable history of moderate to severe rhinoconjunctivitis on exposure to grass

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C3858758
UMLS CUI [1,3]
C0861154
UMLS CUI [1,4]
C1299393
UMLS CUI [1,5]
C0440307
positive skin prick test to grass.
Beschrijving

Positive skin prick test to grass

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C0440307
UMLS CUI [1,3]
C1446409
grass-specific immunoglobulin e (ige) ≥ 0.35 ku/l.
Beschrijving

Immunoglobulin E measurement, specific to grass pollen allergy

Datatype

boolean

Alias
UMLS CUI [1]
C1270900
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of life-threatening asthma.
Beschrijving

History of life-threatening asthma.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0262926
uncontrolled asthma according to gina.
Beschrijving

Uncontrolled asthma, Treatment adjusted per protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1627778
fev1 of <70 % of predicted, regardless of the cause
Beschrijving

Percent predicted FEV1

Datatype

boolean

Alias
UMLS CUI [1]
C0730561
administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease).
Beschrijving

Administration of adrenaline is contraidicated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0014563
history of severe drug allergy or anaphylactic reaction to food.
Beschrijving

History of severe drug allergy | Anaphylactic reaction to food.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0013182
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0685898
a history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Beschrijving

Medical history of any significant disease or disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2826293
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Similar models

Eligibility Seasonal Allergic Rhinitis NCT02161107

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, aged 18-65 years.
boolean
C0001779 (UMLS CUI [1])
Asthma treated by inhaled SABA | Astma treated by inhaled SABA plus low dose-medium dose ICS
Item
asthma treated by inhaled saba or inhaled saba plus low-medium dose ics in 6 weeks prior to randomisation.
boolean
C0004096 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C2917450 (UMLS CUI [1,3])
C0443303 (UMLS CUI [1,4])
C0004096 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C2917450 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
C0332287 (UMLS CUI [2,5])
C2065041 (UMLS CUI [2,6])
C0445550 (UMLS CUI [2,7])
C0439536 (UMLS CUI [2,8])
Reliable history of moderate to severe rhinoconjunctivitis on exposure to grass
Item
a reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to grass for at least the previous two grass seasons.
boolean
C0262926 (UMLS CUI [1,1])
C3858758 (UMLS CUI [1,2])
C0861154 (UMLS CUI [1,3])
C1299393 (UMLS CUI [1,4])
C0440307 (UMLS CUI [1,5])
Positive skin prick test to grass
Item
positive skin prick test to grass.
boolean
C0430561 (UMLS CUI [1,1])
C0440307 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
Immunoglobulin E measurement, specific to grass pollen allergy
Item
grass-specific immunoglobulin e (ige) ≥ 0.35 ku/l.
boolean
C1270900 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
History of life-threatening asthma.
Item
history of life-threatening asthma.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Uncontrolled asthma, Treatment adjusted per protocol
Item
uncontrolled asthma according to gina.
boolean
C0004096 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1627778 (UMLS CUI [1,3])
Percent predicted FEV1
Item
fev1 of <70 % of predicted, regardless of the cause
boolean
C0730561 (UMLS CUI [1])
Administration of adrenaline is contraidicated
Item
administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease).
boolean
C1301624 (UMLS CUI [1,1])
C0014563 (UMLS CUI [1,2])
History of severe drug allergy | Anaphylactic reaction to food.
Item
history of severe drug allergy or anaphylactic reaction to food.
boolean
C0262926 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0685898 (UMLS CUI [2,2])
Medical history of any significant disease or disorder
Item
a history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
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