0 Ratings
ID

14448

Description

Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids (ICS) With or Without Other Controllers; ODM derived from: https://clinicaltrials.gov/show/NCT02449473

Link

https://clinicaltrials.gov/show/NCT02449473

Keywords

Versions (1)
  1. 4/15/16 4/15/16 -
Uploaded on

April 15, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Asthma NCT02449473

    English

    Eligibility Asthma NCT02449473

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02449473
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age 18 to 75 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
    Description

    Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    3. documented treatment with an asthma controller regimen requiring treatment with ics (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
    Description

    Asthma Treatment Protocols | inhaled steroids | Fluticasone propionate Dry Powder Inhaler

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0040808
    UMLS CUI [2]
    C2065041
    UMLS CUI [3,1]
    C0117996
    UMLS CUI [3,2]
    C1967611
    4. additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
    Description

    Additional medication therapy required Asthma control

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3494715
    UMLS CUI [1,2]
    C0004096
    UMLS CUI [1,3]
    C0243148
    5. at enrolment (v1) the subject must have a predicted normal value (pnv) for the morning pre-bronchodilator (bd) fev1>50% and more than 1l.
    Description

    pre bronchodilator FEV1 Morning

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2599602
    UMLS CUI [1,2]
    C0748133
    UMLS CUI [1,3]
    C0332170
    6. post-bd reversibility in fev1 of ≥12% and ≥200 ml at enrolment (v1).
    Description

    post bronchodilator Forced Expiratory Volume in 1 Second Reversibility

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2599594
    UMLS CUI [1,2]
    C3830088
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. history of interstitial lung disease, chronic obstructive pulmonary disease (copd), or other clinically significant lung disease other than asthma.
    Description

    Lung Diseases, Interstitial | Chronic Obstructive Airway Disease | Other Lung diseases | Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206062
    UMLS CUI [2]
    C0024117
    UMLS CUI [3,1]
    C0205394
    UMLS CUI [3,2]
    C0024115
    UMLS CUI [4]
    C0004096
    2. history of anaphylaxis following any biologic therapy.
    Description

    Anaphylaxis Following Biological Response Modifier Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0002792
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0005527
    3. hepatitis b, c or hiv
    Description

    Hepatitis B | Hepatitis C | HIV

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    UMLS CUI [3]
    C0019682
    4. pregnant or breastfeeding
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    5. history of cancer
    Description

    Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    6. current tobacco smoking or a history of tobacco smoking for ≥10 pack-years.
    Description

    Current Smoker | Smoking cigarettes: ____ pack-years history

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3241966
    UMLS CUI [2]
    C2230126
    7. previous receipt of tralokinumab
    Description

    Received tralokinumab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514756
    UMLS CUI [1,2]
    C3658667
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    Similar models

    Eligibility Asthma NCT02449473

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02449473
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. age 18 to 75 years
    boolean
    C0001779 (UMLS CUI [1])
    Asthma
    Item
    2. documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
    boolean
    C0004096 (UMLS CUI [1])
    Asthma Treatment Protocols | inhaled steroids | Fluticasone propionate Dry Powder Inhaler
    Item
    3. documented treatment with an asthma controller regimen requiring treatment with ics (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
    boolean
    C0004096 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    C2065041 (UMLS CUI [2])
    C0117996 (UMLS CUI [3,1])
    C1967611 (UMLS CUI [3,2])
    Additional medication therapy required Asthma control
    Item
    4. additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
    boolean
    C3494715 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    C0243148 (UMLS CUI [1,3])
    pre bronchodilator FEV1 Morning
    Item
    5. at enrolment (v1) the subject must have a predicted normal value (pnv) for the morning pre-bronchodilator (bd) fev1>50% and more than 1l.
    boolean
    C2599602 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    C0332170 (UMLS CUI [1,3])
    post bronchodilator Forced Expiratory Volume in 1 Second Reversibility
    Item
    6. post-bd reversibility in fev1 of ≥12% and ≥200 ml at enrolment (v1).
    boolean
    C2599594 (UMLS CUI [1,1])
    C3830088 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Lung Diseases, Interstitial | Chronic Obstructive Airway Disease | Other Lung diseases | Asthma
    Item
    1. history of interstitial lung disease, chronic obstructive pulmonary disease (copd), or other clinically significant lung disease other than asthma.
    boolean
    C0206062 (UMLS CUI [1])
    C0024117 (UMLS CUI [2])
    C0205394 (UMLS CUI [3,1])
    C0024115 (UMLS CUI [3,2])
    C0004096 (UMLS CUI [4])
    Anaphylaxis Following Biological Response Modifier Therapy
    Item
    2. history of anaphylaxis following any biologic therapy.
    boolean
    C0002792 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0005527 (UMLS CUI [1,3])
    Hepatitis B | Hepatitis C | HIV
    Item
    3. hepatitis b, c or hiv
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    C0019682 (UMLS CUI [3])
    Pregnancy | Breast Feeding
    Item
    4. pregnant or breastfeeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Malignant Neoplasms
    Item
    5. history of cancer
    boolean
    C0006826 (UMLS CUI [1])
    Current Smoker | Smoking cigarettes: ____ pack-years history
    Item
    6. current tobacco smoking or a history of tobacco smoking for ≥10 pack-years.
    boolean
    C3241966 (UMLS CUI [1])
    C2230126 (UMLS CUI [2])
    Received tralokinumab
    Item
    7. previous receipt of tralokinumab
    boolean
    C1514756 (UMLS CUI [1,1])
    C3658667 (UMLS CUI [1,2])
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