0 Evaluaciones
ID

14095

Descripción

Targeted Small Airways Therapy in Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01894048

Link

https://clinicaltrials.gov/show/NCT01894048

Palabras clave

Versiones (1)
  1. 29/3/16 29/3/16 -
Subido en

29 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Asthma NCT01894048

    Inglés

    Eligibility Asthma NCT01894048

    1 formularios  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01894048
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male and female volunteers aged 18-65, with persistent asthma
    Descripción

    Age | Gender | Persistent asthma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C0079399
    UMLS CUI [1,3]
    C3266628
    asthma control questionnaire score >1.0 (at end of run-in)
    Descripción

    Score | Asthma control questionnaire

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0449820
    UMLS CUI [1,2]
    C2919686
    fev1 >60 percent predicted
    Descripción

    FEV1

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0748133
    r5>130% predicted and r5-r20>0.03kpa/l/s
    Descripción

    Total airway resistance | Airway Resistance | Small airways

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0232024
    UMLS CUI [1,2]
    C0001884
    UMLS CUI [1,3]
    C1862763
    ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
    Descripción

    Ability | Spirometry | impulse oscillometry | Bronchial Provocation Tests | Domiciliary Measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C0037981
    UMLS CUI [1,3]
    C3517156
    UMLS CUI [1,4]
    C0006265
    UMLS CUI [1,5]
    C0242485
    UMLS CUI [1,6]
    C0338047
    ability to give informed consent
    Descripción

    Ability | Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C0021430
    asthmatic patients receiving treatment at step 2, 3, or 4 of british thoracic society asthma guidelines
    Descripción

    Asthma | Therapeutic procedure | treatment guideline

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0935576
    ability to withhold long-acting beta-agonists for the duration of the study
    Descripción

    Ability | Withholding Treatment | Adrenergic beta-Agonists

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C0871549
    UMLS CUI [1,3]
    C0001644
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients already receiving extra-fine particle inhaled corticosteroids (qvar, fostair, alvesco)
    Descripción

    inhaled steroids

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2065041
    UMLS CUI [1,2]
    C0731268
    UMLS CUI [2]
    C1174745
    pregnancy or lactation
    Descripción

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    known or suspected sensitivity to the investigational medicinal product
    Descripción

    Hypersensitivity | Investigational New Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    inability to comply with protocol
    Descripción

    Compliance behavior | Limited

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
    Descripción

    Compliance behavior | Limited | Comorbidity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    an asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
    Descripción

    Exacerbation of asthma | systemic steroids | Lower respiratory tract infection | Antibiotics

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0349790
    UMLS CUI [1,2]
    C0332121
    UMLS CUI [1,3]
    C2825233
    UMLS CUI [2,1]
    C0149725
    UMLS CUI [2,2]
    C0003232
    participation in previous trial within 30 days
    Descripción

    Study Subject Participation Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Asthma NCT01894048

    1 formularios
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01894048
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Gender | Persistent asthma
    Item
    male and female volunteers aged 18-65, with persistent asthma
    boolean
    C0001779 (UMLS CUI [1,1])
    C0079399 (UMLS CUI [1,2])
    C3266628 (UMLS CUI [1,3])
    Score | Asthma control questionnaire
    Item
    asthma control questionnaire score >1.0 (at end of run-in)
    boolean
    C0449820 (UMLS CUI [1,1])
    C2919686 (UMLS CUI [1,2])
    FEV1
    Item
    fev1 >60 percent predicted
    boolean
    C0748133 (UMLS CUI [1])
    Total airway resistance | Airway Resistance | Small airways
    Item
    r5>130% predicted and r5-r20>0.03kpa/l/s
    boolean
    C0232024 (UMLS CUI [1,1])
    C0001884 (UMLS CUI [1,2])
    C1862763 (UMLS CUI [1,3])
    Ability | Spirometry | impulse oscillometry | Bronchial Provocation Tests | Domiciliary Measurement
    Item
    ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
    boolean
    C0085732 (UMLS CUI [1,1])
    C0037981 (UMLS CUI [1,2])
    C3517156 (UMLS CUI [1,3])
    C0006265 (UMLS CUI [1,4])
    C0242485 (UMLS CUI [1,5])
    C0338047 (UMLS CUI [1,6])
    Ability | Informed Consent
    Item
    ability to give informed consent
    boolean
    C0085732 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Asthma | Therapeutic procedure | treatment guideline
    Item
    asthmatic patients receiving treatment at step 2, 3, or 4 of british thoracic society asthma guidelines
    boolean
    C0004096 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0935576 (UMLS CUI [1,3])
    Ability | Withholding Treatment | Adrenergic beta-Agonists
    Item
    ability to withhold long-acting beta-agonists for the duration of the study
    boolean
    C0085732 (UMLS CUI [1,1])
    C0871549 (UMLS CUI [1,2])
    C0001644 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    inhaled steroids
    Item
    patients already receiving extra-fine particle inhaled corticosteroids (qvar, fostair, alvesco)
    boolean
    C2065041 (UMLS CUI [1,1])
    C0731268 (UMLS CUI [1,2])
    C1174745 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnancy or lactation
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Hypersensitivity | Investigational New Drugs
    Item
    known or suspected sensitivity to the investigational medicinal product
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Compliance behavior | Limited
    Item
    inability to comply with protocol
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Compliance behavior | Limited | Comorbidity
    Item
    any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    Exacerbation of asthma | systemic steroids | Lower respiratory tract infection | Antibiotics
    Item
    an asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
    boolean
    C0349790 (UMLS CUI [1,1])
    C0332121 (UMLS CUI [1,2])
    C2825233 (UMLS CUI [1,3])
    C0149725 (UMLS CUI [2,1])
    C0003232 (UMLS CUI [2,2])
    Study Subject Participation Status
    Item
    participation in previous trial within 30 days
    boolean
    C2348568 (UMLS CUI [1])
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