0 Ratings
ID

43925

Description

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Inadequately Controlled Asthma Subjects With High Bronchodilator Reversibility; ODM derived from: https://clinicaltrials.gov/show/NCT01902290

Link

https://clinicaltrials.gov/show/NCT01902290

Keywords

Versions (2)
  1. 3/29/16 3/29/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Asthma NCT01902290

    English

    Eligibility Asthma NCT01902290

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01902290
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of asthma, and presently has reversibility over pre-bronchodilator fev1 of
    Description

    Asthma | Reversibility | pre bronchodilator | FEV1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0449261
    UMLS CUI [1,3]
    C2599602
    UMLS CUI [1,4]
    C0748133
    ≥ 20 percent at screening
    Description

    FEV1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0748133
    percent of predicted fev1 ≥ 40% and ≤ 80% at screening
    Description

    Percent predicted FEV1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0730561
    ics ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
    Description

    Inhaled steroids | fluticasone

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2065041
    UMLS CUI [1,2]
    C0082607
    ongoing asthma symptoms with acq composite score at screening and baseline ≥ 1.5 points
    Description

    Score | Asthma control questionnaire | Asthma | Symptoms | Continuous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0449820
    UMLS CUI [1,2]
    C2919686
    UMLS CUI [1,3]
    C0004096
    UMLS CUI [1,4]
    C1457887
    UMLS CUI [1,5]
    C0549178
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
    Description

    Chronic Obstructive Airway Disease | Other chronic pulmonary disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    UMLS CUI [2,1]
    C0810290
    UMLS CUI [2,2]
    C0004096
    history of allergic bronchopulmonary aspergillosis
    Description

    Aspergillosis, Allergic Bronchopulmonary

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004031
    respiratory infection within 4 weeks of screening or 1 week of baseline visit
    Description

    Respiratory Tract Infections

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035243
    subject has known history of crohn's disease subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
    Description

    Crohn Disease | Comorbidity | Laboratory abnormalities

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010346
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C1853129
    subject has previously used any anti-il17 biologic therapy
    Description

    Interleukin-17 | Therapeutic procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0384648
    UMLS CUI [1,2]
    C0087111
    subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
    Description

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
    Description

    Female | Unwilling | Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0086287
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0700589
    subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
    Description

    Severe depression | Suicidal behavior

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0588008
    UMLS CUI [1,2]
    C0679604
    UMLS CUI [2,1]
    C1760428
    UMLS CUI [2,2]
    C3888485
    subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
    Description

    Mental disorders | Substance abuse problem

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2,1]
    C0740858
    UMLS CUI [2,2]
    C0035647
    UMLS CUI [2,3]
    C1113679
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    Similar models

    Eligibility Asthma NCT01902290

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01902290
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Asthma | Reversibility | pre bronchodilator | FEV1
    Item
    diagnosis of asthma, and presently has reversibility over pre-bronchodilator fev1 of
    boolean
    C0004096 (UMLS CUI [1,1])
    C0449261 (UMLS CUI [1,2])
    C2599602 (UMLS CUI [1,3])
    C0748133 (UMLS CUI [1,4])
    FEV1
    Item
    ≥ 20 percent at screening
    boolean
    C0748133 (UMLS CUI [1])
    Percent predicted FEV1
    Item
    percent of predicted fev1 ≥ 40% and ≤ 80% at screening
    boolean
    C0730561 (UMLS CUI [1])
    Inhaled steroids | fluticasone
    Item
    ics ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
    boolean
    C2065041 (UMLS CUI [1,1])
    C0082607 (UMLS CUI [1,2])
    Score | Asthma control questionnaire | Asthma | Symptoms | Continuous
    Item
    ongoing asthma symptoms with acq composite score at screening and baseline ≥ 1.5 points
    boolean
    C0449820 (UMLS CUI [1,1])
    C2919686 (UMLS CUI [1,2])
    C0004096 (UMLS CUI [1,3])
    C1457887 (UMLS CUI [1,4])
    C0549178 (UMLS CUI [1,5])
    Item Group
    C0680251 (UMLS CUI)
    Chronic Obstructive Airway Disease | Other chronic pulmonary disease
    Item
    history of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
    boolean
    C0024117 (UMLS CUI [1])
    C0810290 (UMLS CUI [2,1])
    C0004096 (UMLS CUI [2,2])
    Aspergillosis, Allergic Bronchopulmonary
    Item
    history of allergic bronchopulmonary aspergillosis
    boolean
    C0004031 (UMLS CUI [1])
    Respiratory Tract Infections
    Item
    respiratory infection within 4 weeks of screening or 1 week of baseline visit
    boolean
    C0035243 (UMLS CUI [1])
    Crohn Disease | Comorbidity | Laboratory abnormalities
    Item
    subject has known history of crohn's disease subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
    boolean
    C0010346 (UMLS CUI [1])
    C0009488 (UMLS CUI [2,1])
    C1853129 (UMLS CUI [2,2])
    Interleukin-17 | Therapeutic procedure
    Item
    subject has previously used any anti-il17 biologic therapy
    boolean
    C0384648 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding | Pregnancy, Planned
    Item
    subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Female | Unwilling | Contraceptive methods
    Item
    female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
    boolean
    C0086287 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    Severe depression | Suicidal behavior
    Item
    subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
    boolean
    C0588008 (UMLS CUI [1,1])
    C0679604 (UMLS CUI [1,2])
    C1760428 (UMLS CUI [2,1])
    C3888485 (UMLS CUI [2,2])
    Mental disorders | Substance abuse problem
    Item
    subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
    boolean
    C0004936 (UMLS CUI [1])
    C0740858 (UMLS CUI [2,1])
    C0035647 (UMLS CUI [2,2])
    C1113679 (UMLS CUI [2,3])
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