ID

38471

Description

Omalizumab in Non-atopic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01113437

Link

https://clinicaltrials.gov/show/NCT01113437

Keywords

Versions (1)
  1. 10/21/19 10/21/19 -
Copyright Holder

See clinicaltrials.gov

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October 21, 2019

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License

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT01113437

English

Eligibility Bronchial Asthma NCT01113437

1 forms  
Criteria
Description

Criteria

males and females aged 18 to 60 years inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
moderate or severe non-atopic asthma as defined below treated with inhaled corticosteroids for at least 6 months.
Description

Allergic asthma Moderate | Allergic asthma Severe | Adrenal Cortex Hormones by Inhalation

Data type

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0155877
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
daytime and nighttime symptoms at least 3 days per week in the last 3 months prior to screening visit(despite taking inhaled corticosteroids with or without beta-2-agonists or leukotriene blockers.
Description

Asthma daytime symptoms days/week Duration | Asthma nighttime symptoms days/week Duration | Adrenal Cortex Hormones by Inhalation | Adrenergic beta-2 Receptor Agonists | Adrenergic beta-2 Receptor Agonists Absent | Leukotriene Antagonists | Leukotriene Antagonists Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1276804
UMLS CUI [1,2]
C0677547
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C2957235
UMLS CUI [2,2]
C0677547
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
UMLS CUI [4]
C2936789
UMLS CUI [5,1]
C2936789
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0595726
UMLS CUI [7,1]
C0595726
UMLS CUI [7,2]
C0332197
pre-bronchodilator fev1 40-80% of the predicted; reversibility equal to or more than 12% in response to inhaled beta-2-agonists documented at any time within the past 2 years.
Description

Percent predicted FEV1 pre bronchodilator | Reversibility Percentage | Response Adrenergic beta-2 Receptor Agonists by Inhalation

Data type

boolean

Alias
UMLS CUI [1,1]
C0730561
UMLS CUI [1,2]
C2599602
UMLS CUI [2,1]
C0449261
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C2936789
UMLS CUI [3,3]
C0205535
negative skin prick and/or in vitro ige tests to a range of 12 common aeroallergens(pollens:grass, hazel, alder, birch; danders: cat, dog; dust mite: d.pteronyssinus, d.farinae; moulds: cladosporium, aspergillus, alternaria).
Description

Skin prick test Negative | ige test in vitro Negative | Aeroallergen Common Quantity | Pollen | Poaceae | Corylus | Alder | Betula Genus | Dander | Felis catus | Canis familiaris | Pyroglyphidae | Dermatophagoides pteronyssinus | Dermatophagoides farinae | Filamentous fungus | Cladosporium | Aspergillus | Alternaria

Data type

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0851103
UMLS CUI [2,2]
C1533691
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0001697
UMLS CUI [3,2]
C0205214
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0032385
UMLS CUI [5]
C0018210
UMLS CUI [6]
C0330325
UMLS CUI [7]
C0330318
UMLS CUI [8]
C0330312
UMLS CUI [9]
C0222058
UMLS CUI [10]
C0007450
UMLS CUI [11]
C0012984
UMLS CUI [12]
C0998367
UMLS CUI [13]
C1122992
UMLS CUI [14]
C0323677
UMLS CUI [15]
C0369241
UMLS CUI [16]
C0008886
UMLS CUI [17]
C0004034
UMLS CUI [18]
C0002343
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoking within the past year or total smoking history more than 0.5 pack years.
Description

Tobacco use | Smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
pregnant or lactating females or those at risk of pregnancy.
Description

Pregnancy | Breast Feeding | At risk Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0032961
treatment with more than 2000 mcg/day beclometasone, 1600 mcg/day budesonide or 1000 mcg/day fluticasone by inhalation or regular systemic corticosteroid at screening.
Description

Beclomethasone by Inhalation U/day | Budesonide by Inhalation U/day | Fluticasone by Inhalation U/day | CORTICOSTEROIDS FOR SYSTEMIC USE Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0004905
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0054201
UMLS CUI [2,2]
C0205535
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0082607
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C3653708
UMLS CUI [4,2]
C0205272
hospitalization for asthma or exacerbation requiring systemic corticosteroid therapy within 3 months of the screening visit.
Description

Hospitalization Asthma | Exacerbation of asthma Requirement Systemic Corticosteroid Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0349790
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C4053960
history of life threatening asthma, defined as an asthma episode that required intubations and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures.
Description

Asthma Life Threatening | Episode of Asthma Requirement Intubation | Episode of Asthma Associated with Hypercapnia | Episode of Asthma Associated with Respiratory arrest | Episode of Asthma Associated with Hypoxic convulsions

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0021925
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0004096
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C0020440
UMLS CUI [4,1]
C0332189
UMLS CUI [4,2]
C0004096
UMLS CUI [4,3]
C0332281
UMLS CUI [4,4]
C0162297
UMLS CUI [5,1]
C0332189
UMLS CUI [5,2]
C0004096
UMLS CUI [5,3]
C0332281
UMLS CUI [5,4]
C1843573
patients in whom, in the opinion of the study investigators, omalizumab therapy might normally require precaution (history of autoimmune disease, renal or hepatic impairment, hyperimmunoglobulin e syndrome, allergic bronchopulmonary aspergillosis and diabetes mellitus)
Description

Omalizumab Requirement Precaution | Autoimmune Disease | Renal Insufficiency | Hepatic impairment | Hyperimmunoglobulin e syndrome | Aspergillosis, Allergic Bronchopulmonary | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1882442
UMLS CUI [2]
C0004364
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0948807
UMLS CUI [5]
C3887645
UMLS CUI [6]
C0004031
UMLS CUI [7]
C0011849
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Similar models

Eligibility Bronchial Asthma NCT01113437

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
males and females aged 18 to 60 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Allergic asthma Moderate | Allergic asthma Severe | Adrenal Cortex Hormones by Inhalation
Item
moderate or severe non-atopic asthma as defined below treated with inhaled corticosteroids for at least 6 months.
boolean
C0155877 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0155877 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
Asthma daytime symptoms days/week Duration | Asthma nighttime symptoms days/week Duration | Adrenal Cortex Hormones by Inhalation | Adrenergic beta-2 Receptor Agonists | Adrenergic beta-2 Receptor Agonists Absent | Leukotriene Antagonists | Leukotriene Antagonists Absent
Item
daytime and nighttime symptoms at least 3 days per week in the last 3 months prior to screening visit(despite taking inhaled corticosteroids with or without beta-2-agonists or leukotriene blockers.
boolean
C1276804 (UMLS CUI [1,1])
C0677547 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C2957235 (UMLS CUI [2,1])
C0677547 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C2936789 (UMLS CUI [4])
C2936789 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0595726 (UMLS CUI [6])
C0595726 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Percent predicted FEV1 pre bronchodilator | Reversibility Percentage | Response Adrenergic beta-2 Receptor Agonists by Inhalation
Item
pre-bronchodilator fev1 40-80% of the predicted; reversibility equal to or more than 12% in response to inhaled beta-2-agonists documented at any time within the past 2 years.
boolean
C0730561 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C0449261 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1704632 (UMLS CUI [3,1])
C2936789 (UMLS CUI [3,2])
C0205535 (UMLS CUI [3,3])
Skin prick test Negative | ige test in vitro Negative | Aeroallergen Common Quantity | Pollen | Poaceae | Corylus | Alder | Betula Genus | Dander | Felis catus | Canis familiaris | Pyroglyphidae | Dermatophagoides pteronyssinus | Dermatophagoides farinae | Filamentous fungus | Cladosporium | Aspergillus | Alternaria
Item
negative skin prick and/or in vitro ige tests to a range of 12 common aeroallergens(pollens:grass, hazel, alder, birch; danders: cat, dog; dust mite: d.pteronyssinus, d.farinae; moulds: cladosporium, aspergillus, alternaria).
boolean
C0430561 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0851103 (UMLS CUI [2,1])
C1533691 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0001697 (UMLS CUI [3,1])
C0205214 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0032385 (UMLS CUI [4])
C0018210 (UMLS CUI [5])
C0330325 (UMLS CUI [6])
C0330318 (UMLS CUI [7])
C0330312 (UMLS CUI [8])
C0222058 (UMLS CUI [9])
C0007450 (UMLS CUI [10])
C0012984 (UMLS CUI [11])
C0998367 (UMLS CUI [12])
C1122992 (UMLS CUI [13])
C0323677 (UMLS CUI [14])
C0369241 (UMLS CUI [15])
C0008886 (UMLS CUI [16])
C0004034 (UMLS CUI [17])
C0002343 (UMLS CUI [18])
Item Group
C0680251 (UMLS CUI)
Tobacco use | Smoking cigarettes: ____ pack-years history
Item
smoking within the past year or total smoking history more than 0.5 pack years.
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Pregnancy | Breast Feeding | At risk Pregnancy
Item
pregnant or lactating females or those at risk of pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
Beclomethasone by Inhalation U/day | Budesonide by Inhalation U/day | Fluticasone by Inhalation U/day | CORTICOSTEROIDS FOR SYSTEMIC USE Regular
Item
treatment with more than 2000 mcg/day beclometasone, 1600 mcg/day budesonide or 1000 mcg/day fluticasone by inhalation or regular systemic corticosteroid at screening.
boolean
C0004905 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0054201 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0082607 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C3653708 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
Hospitalization Asthma | Exacerbation of asthma Requirement Systemic Corticosteroid Therapy
Item
hospitalization for asthma or exacerbation requiring systemic corticosteroid therapy within 3 months of the screening visit.
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C4053960 (UMLS CUI [2,3])
Asthma Life Threatening | Episode of Asthma Requirement Intubation | Episode of Asthma Associated with Hypercapnia | Episode of Asthma Associated with Respiratory arrest | Episode of Asthma Associated with Hypoxic convulsions
Item
history of life threatening asthma, defined as an asthma episode that required intubations and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0021925 (UMLS CUI [2,4])
C0332189 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C0020440 (UMLS CUI [3,4])
C0332189 (UMLS CUI [4,1])
C0004096 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0162297 (UMLS CUI [4,4])
C0332189 (UMLS CUI [5,1])
C0004096 (UMLS CUI [5,2])
C0332281 (UMLS CUI [5,3])
C1843573 (UMLS CUI [5,4])
Omalizumab Requirement Precaution | Autoimmune Disease | Renal Insufficiency | Hepatic impairment | Hyperimmunoglobulin e syndrome | Aspergillosis, Allergic Bronchopulmonary | Diabetes Mellitus
Item
patients in whom, in the opinion of the study investigators, omalizumab therapy might normally require precaution (history of autoimmune disease, renal or hepatic impairment, hyperimmunoglobulin e syndrome, allergic bronchopulmonary aspergillosis and diabetes mellitus)
boolean
C0966225 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1882442 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0948807 (UMLS CUI [4])
C3887645 (UMLS CUI [5])
C0004031 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
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