ID

30824

Beskrivning

Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01362621

Länk

https://clinicaltrials.gov/show/NCT01362621

Nyckelord

Versioner (2)
  1. 2018-06-23 2018-06-23 -
  2. 2018-06-23 2018-06-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Moderate to Severe Allergic Asthma NCT01362621

Engelsk

Eligibility Moderate to Severe Allergic Asthma NCT01362621

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
total ige ≥30 iu (historical values obtained within 3 months of screening visit will be accepted). if historic result not available, to be obtained at screening visit.
Beskrivning

Immunoglobulin E measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202086
diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
Beskrivning

Asthma Disease length | Symptoms Consistent with Asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0004096
documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific ige test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
Beskrivning

Perennial allergy Aeroallergen Quantity | Skin prick test Positive | IgE test in vitro Pyroglyphidae | IgE test in vitro Cat dander | IgE test in vitro Dog dander | IgE test in vitro Dictyoptera

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2721639
UMLS CUI [1,2]
C0001697
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0430561
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0851103
UMLS CUI [3,2]
C1533691
UMLS CUI [3,3]
C0998367
UMLS CUI [4,1]
C0851103
UMLS CUI [4,2]
C1533691
UMLS CUI [4,3]
C0440456
UMLS CUI [5,1]
C0851103
UMLS CUI [5,2]
C1533691
UMLS CUI [5,3]
C0440458
UMLS CUI [6,1]
C0851103
UMLS CUI [6,2]
C1533691
UMLS CUI [6,3]
C0009208
prescribed inhaled corticosteroid for at least 3 months prior to screening (a) and having evidence of inadequately controlled disease either with at least one from list (b) or history of asthma-related exacerbations as defined in (c). [e.g., a and (b or c)]
Beskrivning

Inhaled steroids | Disease Poorly controlled | Exacerbation of asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0349790
a. fluticasone dpi > 200 mcg/day or equivalent ex-valve dose ics, or if ≤ 200 mcg fluticasone dpi or equivalent plus another daily controller medication (i.e. laba, leukotriene antagonist or theophylline)
Beskrivning

Fluticasone U/day | Inhaled steroids Dose Equivalent | Adrenergic beta-Agonists Active Long-term | Leukotriene Antagonists | Theophylline

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0082607
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205163
UMLS CUI [3,1]
C0001644
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
UMLS CUI [4]
C0595726
UMLS CUI [5]
C0039771
b. at least one of the following in the preceding 4 weeks prior to the screening visit:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
on average asthma symptoms > 2 days/week or multiple times in a day on ≤ 2 days/week
Beskrivning

Asthma Symptoms Average days/week | Asthma Symptoms Quantity Frequency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1510992
UMLS CUI [1,4]
C0677547
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0439603
nighttime awakenings ≥ 2 times/month due to asthma symptoms
Beskrivning

Nocturnal awakening Frequency | Etiology Asthma Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0860510
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C1457887
use of sabas > 2 times/week on average
Beskrivning

Adrenergic beta-Agonists Active Short-term Frequency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001644
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443303
UMLS CUI [1,4]
C0439603
some limitation in activity due to asthma
Beskrivning

Limitation Physical activity Due to Asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449295
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0004096
on spirometric evaluation, fev1 ≤ 80% of predicted, fev1/fvc ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best
Beskrivning

Spirometry Evaluation | FEV1 | FEV1/FVC ratio | Peak expiratory flow rate measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037981
UMLS CUI [1,2]
C1261322
UMLS CUI [2]
C0849974
UMLS CUI [3]
C0429745
UMLS CUI [4]
C0030735
c. minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit
Beskrivning

Exacerbation of asthma Quantity Minimum | Patient need for Adrenal Cortex Hormones Oral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1524031
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C1527415
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of visit 1 or a biologic agent within 120 days of visit 1
Beskrivning

Study Subject Participation Status | Therapeutic agent | Biological Factors

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0304231
UMLS CUI [3]
C0005515
subjects with a history of prior use of omalizumab
Beskrivning

omalizumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0966225
subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
Beskrivning

Medical condition Severe Study Subject Participation Status Excluded | Protocol Compliance Impaired | Nervous system disorder Severe | Developmental Disabilities Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0332196
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0221099
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0008073
UMLS CUI [4,2]
C0205082
subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
Beskrivning

Respiration Disorders | Exception Allergic asthma | Aspergillosis, Allergic Bronchopulmonary | Cystic Fibrosis | Bronchiectasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0155877
UMLS CUI [3]
C0004031
UMLS CUI [4]
C0010674
UMLS CUI [5]
C0006267
subjects with elevated serum ige levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin e syndrome, and wiskott-aldrich syndrome
Beskrivning

Elevated levels of serum IgE | Exception Relationship Hypersensitivity | Parasitic Diseases | Job Syndrome | Wiskott-Aldrich Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C3279428
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0020517
UMLS CUI [3]
C0030499
UMLS CUI [4]
C3887645
UMLS CUI [5]
C0043194
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Moderate to Severe Allergic Asthma NCT01362621

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Immunoglobulin E measurement
Item
total ige ≥30 iu (historical values obtained within 3 months of screening visit will be accepted). if historic result not available, to be obtained at screening visit.
boolean
C0202086 (UMLS CUI [1])
Asthma Disease length | Symptoms Consistent with Asthma
Item
diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
boolean
C0004096 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
Perennial allergy Aeroallergen Quantity | Skin prick test Positive | IgE test in vitro Pyroglyphidae | IgE test in vitro Cat dander | IgE test in vitro Dog dander | IgE test in vitro Dictyoptera
Item
documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific ige test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
boolean
C2721639 (UMLS CUI [1,1])
C0001697 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0430561 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0851103 (UMLS CUI [3,1])
C1533691 (UMLS CUI [3,2])
C0998367 (UMLS CUI [3,3])
C0851103 (UMLS CUI [4,1])
C1533691 (UMLS CUI [4,2])
C0440456 (UMLS CUI [4,3])
C0851103 (UMLS CUI [5,1])
C1533691 (UMLS CUI [5,2])
C0440458 (UMLS CUI [5,3])
C0851103 (UMLS CUI [6,1])
C1533691 (UMLS CUI [6,2])
C0009208 (UMLS CUI [6,3])
Inhaled steroids | Disease Poorly controlled | Exacerbation of asthma
Item
prescribed inhaled corticosteroid for at least 3 months prior to screening (a) and having evidence of inadequately controlled disease either with at least one from list (b) or history of asthma-related exacerbations as defined in (c). [e.g., a and (b or c)]
boolean
C2065041 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0349790 (UMLS CUI [3])
Fluticasone U/day | Inhaled steroids Dose Equivalent | Adrenergic beta-Agonists Active Long-term | Leukotriene Antagonists | Theophylline
Item
a. fluticasone dpi > 200 mcg/day or equivalent ex-valve dose ics, or if ≤ 200 mcg fluticasone dpi or equivalent plus another daily controller medication (i.e. laba, leukotriene antagonist or theophylline)
boolean
C0082607 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0001644 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0595726 (UMLS CUI [4])
C0039771 (UMLS CUI [5])
Criteria Fulfill
Item
b. at least one of the following in the preceding 4 weeks prior to the screening visit:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Asthma Symptoms Average days/week | Asthma Symptoms Quantity Frequency
Item
on average asthma symptoms > 2 days/week or multiple times in a day on ≤ 2 days/week
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0677547 (UMLS CUI [1,4])
C0004096 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0439603 (UMLS CUI [2,4])
Nocturnal awakening Frequency | Etiology Asthma Symptoms
Item
nighttime awakenings ≥ 2 times/month due to asthma symptoms
boolean
C0860510 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Adrenergic beta-Agonists Active Short-term Frequency
Item
use of sabas > 2 times/week on average
boolean
C0001644 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443303 (UMLS CUI [1,3])
C0439603 (UMLS CUI [1,4])
Limitation Physical activity Due to Asthma
Item
some limitation in activity due to asthma
boolean
C0449295 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0004096 (UMLS CUI [1,4])
Spirometry Evaluation | FEV1 | FEV1/FVC ratio | Peak expiratory flow rate measurement
Item
on spirometric evaluation, fev1 ≤ 80% of predicted, fev1/fvc ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best
boolean
C0037981 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0849974 (UMLS CUI [2])
C0429745 (UMLS CUI [3])
C0030735 (UMLS CUI [4])
Exacerbation of asthma Quantity Minimum | Patient need for Adrenal Cortex Hormones Oral
Item
c. minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit
boolean
C0349790 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Therapeutic agent | Biological Factors
Item
subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of visit 1 or a biologic agent within 120 days of visit 1
boolean
C2348568 (UMLS CUI [1])
C0304231 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
omalizumab
Item
subjects with a history of prior use of omalizumab
boolean
C0966225 (UMLS CUI [1])
Medical condition Severe Study Subject Participation Status Excluded | Protocol Compliance Impaired | Nervous system disorder Severe | Developmental Disabilities Severe
Item
subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,4])
C0525058 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0008073 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Respiration Disorders | Exception Allergic asthma | Aspergillosis, Allergic Bronchopulmonary | Cystic Fibrosis | Bronchiectasis
Item
subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
boolean
C0035204 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0155877 (UMLS CUI [2,2])
C0004031 (UMLS CUI [3])
C0010674 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
Elevated levels of serum IgE | Exception Relationship Hypersensitivity | Parasitic Diseases | Job Syndrome | Wiskott-Aldrich Syndrome
Item
subjects with elevated serum ige levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin e syndrome, and wiskott-aldrich syndrome
boolean
C3279428 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
C0030499 (UMLS CUI [3])
C3887645 (UMLS CUI [4])
C0043194 (UMLS CUI [5])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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