ID

14548

Beskrivning

Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder; ODM derived from: https://clinicaltrials.gov/show/NCT01738087

Länk

https://clinicaltrials.gov/show/NCT01738087

Nyckelord

  1. 2016-04-20 2016-04-20 -
Uppladdad den

20 april 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Asthmatic NCT01738087

    Eligibility Asthmatic NCT01738087

    1. StudyEvent: Eligibility
      1. Eligibility Asthmatic NCT01738087
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of asthma as defined by global initiative for asthma (gina) 2011
    Beskrivning

    Asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    asthmatic patients already treated with low daily doses of inhaled corticosteroids (ics) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ics/long acting beta2 agonists (laba) fixed combinations.
    Beskrivning

    Therapeutic procedure Inhaled steroids | Budesonide | Adrenergic beta-2 Receptor Agonists

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2065041
    UMLS CUI [2]
    C0054201
    UMLS CUI [3]
    C2936789
    patients with forced expiratory volume in 1 sec (fev1) >= 70 % of predicted values
    Beskrivning

    FEV1

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0748133
    non or ex-smokers
    Beskrivning

    Non-smoker | Former smoker

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0337672
    UMLS CUI [2]
    C0337671
    body mass index (bmi) >= 18.5 and <= 32 kg/m2
    Beskrivning

    Body mass index

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pregnant or lactating women unless using acceptable methods of contraception
    Beskrivning

    Pregnancy | Breast Feeding | Contraceptive methods

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0700589
    diagnosis of chronic obstructive pulmonary disease (copd)
    Beskrivning

    Chronic Obstructive Airway Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    history of near fatal asthma
    Beskrivning

    Asthma Near Fatal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C1706276
    UMLS CUI [1,3]
    C1302234
    patients with abnormal qtcf at screening visit
    Beskrivning

    QTcF Abnormal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1882513
    UMLS CUI [1,2]
    C0205161
    hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
    Beskrivning

    Exacerbation of asthma | Hospitalization

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    UMLS CUI [2]
    C0019993
    lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
    Beskrivning

    Lower respiratory tract infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149725
    history of drug addiction or excessive use of alcohol ;
    Beskrivning

    Substance abuse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0740858
    diagnosis of restrictive lung disease.
    Beskrivning

    Restrictive lung disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0085581
    patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
    Beskrivning

    Oral steroid therapy | Parenteral steroid treatment | Parenteral Adrenal Cortex Hormones Depot Preparations

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0574135
    UMLS CUI [2]
    C3840673
    UMLS CUI [3,1]
    C1518896
    UMLS CUI [3,2]
    C0001617
    UMLS CUI [3,3]
    C0086129
    significant medical history or any laboratory abnormality indicative of a significant underlying condition
    Beskrivning

    Significant Medical History | Laboratory test result abnormal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0750502
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2]
    C0438215

    Similar models

    Eligibility Asthmatic NCT01738087

    1. StudyEvent: Eligibility
      1. Eligibility Asthmatic NCT01738087
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Asthma
    Item
    diagnosis of asthma as defined by global initiative for asthma (gina) 2011
    boolean
    C0004096 (UMLS CUI [1])
    Therapeutic procedure Inhaled steroids | Budesonide | Adrenergic beta-2 Receptor Agonists
    Item
    asthmatic patients already treated with low daily doses of inhaled corticosteroids (ics) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ics/long acting beta2 agonists (laba) fixed combinations.
    boolean
    C0087111 (UMLS CUI [1,1])
    C2065041 (UMLS CUI [1,2])
    C0054201 (UMLS CUI [2])
    C2936789 (UMLS CUI [3])
    FEV1
    Item
    patients with forced expiratory volume in 1 sec (fev1) >= 70 % of predicted values
    boolean
    C0748133 (UMLS CUI [1])
    Non-smoker | Former smoker
    Item
    non or ex-smokers
    boolean
    C0337672 (UMLS CUI [1])
    C0337671 (UMLS CUI [2])
    Body mass index
    Item
    body mass index (bmi) >= 18.5 and <= 32 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding | Contraceptive methods
    Item
    pregnant or lactating women unless using acceptable methods of contraception
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    Chronic Obstructive Airway Disease
    Item
    diagnosis of chronic obstructive pulmonary disease (copd)
    boolean
    C0024117 (UMLS CUI [1])
    Asthma Near Fatal
    Item
    history of near fatal asthma
    boolean
    C0004096 (UMLS CUI [1,1])
    C1706276 (UMLS CUI [1,2])
    C1302234 (UMLS CUI [1,3])
    QTcF Abnormal
    Item
    patients with abnormal qtcf at screening visit
    boolean
    C1882513 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    Exacerbation of asthma | Hospitalization
    Item
    hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
    boolean
    C0349790 (UMLS CUI [1])
    C0019993 (UMLS CUI [2])
    Lower respiratory tract infection
    Item
    lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
    boolean
    C0149725 (UMLS CUI [1])
    Substance abuse
    Item
    history of drug addiction or excessive use of alcohol ;
    boolean
    C0740858 (UMLS CUI [1])
    Restrictive lung disease
    Item
    diagnosis of restrictive lung disease.
    boolean
    C0085581 (UMLS CUI [1])
    Oral steroid therapy | Parenteral steroid treatment | Parenteral Adrenal Cortex Hormones Depot Preparations
    Item
    patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
    boolean
    C0574135 (UMLS CUI [1])
    C3840673 (UMLS CUI [2])
    C1518896 (UMLS CUI [3,1])
    C0001617 (UMLS CUI [3,2])
    C0086129 (UMLS CUI [3,3])
    Significant Medical History | Laboratory test result abnormal
    Item
    significant medical history or any laboratory abnormality indicative of a significant underlying condition
    boolean
    C0750502 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0438215 (UMLS CUI [2])

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