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ID

30824

Description

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

Link

https://clinicaltrials.gov/show/NCT01362621

Keywords

Versions (2)
  1. 6/23/18 6/23/18 -
  2. 6/23/18 6/23/18 -
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See clinicaltrials.gov

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June 23, 2018

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Creative Commons BY 4.0
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    Eligibility Moderate to Severe Allergic Asthma NCT01362621

    English

    Eligibility Moderate to Severe Allergic Asthma NCT01362621

    1 forms  
    Inclusion Criteria
    Description

    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.
    Description

    Immunoglobulin E measurement

    Data type

    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
    Description

    Asthma Disease length | Symptoms Consistent with Asthma

    Data type

    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
    Description

    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

    Data type

    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)]
    Description

    Inhaled steroids | Disease Poorly controlled | Exacerbation of asthma

    Data type

    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)
    Description

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

    Data type

    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:
    Description

    Criteria Fulfill

    Data type

    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
    Description

    Asthma Symptoms Average days/week | Asthma Symptoms Quantity Frequency

    Data type

    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
    Description

    Nocturnal awakening Frequency | Etiology Asthma Symptoms

    Data type

    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
    Description

    Adrenergic beta-Agonists Active Short-term Frequency

    Data type

    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
    Description

    Limitation Physical activity Due to Asthma

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

    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
    Description

    Study Subject Participation Status | Therapeutic agent | Biological Factors

    Data type

    boolean

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

    omalizumab

    Data type

    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)
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

    Eligibility Criteria Study Protocol

    Data type

    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 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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