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14392

Beskrivning

Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00529529

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https://clinicaltrials.gov/show/NCT00529529

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  1. 2016-04-13 2016-04-13 -
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13 april 2016

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    Eligibility Asthma NCT00529529

    Engelsk

    Eligibility Asthma NCT00529529

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00529529
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or institutional review board/independent ethics committee/research ethics board [irb/iec/reb] approval) who have signed an informed consent form.
    Beskrivning

    age and informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2]
    C0021430 (Informed Consent)
    2. patients with moderate to severe persistent asthma, diagnosed according to the global initiative for asthma (gina) guidelines (updated 2006) and who additionally meet the following criteria:
    Beskrivning

    moderate to severe persistent asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1960047 (Moderate persistent asthma)
    SNOMED
    427295004
    UMLS CUI [2]
    C1960048 (Severe persistent asthma)
    SNOMED
    426656000
    patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening.
    Beskrivning

    bronchodilator and beclomethasone dipropionate

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006280 (Bronchodilator Agents)
    SNOMED
    353866001
    UMLS CUI [2,1]
    C0004906 (beclomethasone dipropionate)
    SNOMED
    116575004
    UMLS CUI [2,2]
    C2348070 (Daily Dose)
    UMLS CUI [3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    patients whose forced expiratory volume in 1 second (fev1) is ≥ 50% of the predicted normal value.
    Beskrivning

    fev1

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in fev1, after inhaling 200
    Beskrivning

    fev1 post-bronchodilator

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI [1,2]
    C2599594 (post bronchodilator)
    LOINC
    LP71934-1
    μg salbutamol.
    Beskrivning

    salbutamol

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001927 (albuterol)
    SNOMED
    372897005
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception.
    Beskrivning

    pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3]
    C3831118 (Childbearing Potential)
    UMLS CUI [4]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [5]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    2. patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years.
    Beskrivning

    smoking history

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1519384 (Tobacco Smoking History)
    UMLS CUI [2]
    C1277691 (Pack years)
    SNOMED
    315609007
    3. patients who suffer from chronic obstructive pulmonary disease (copd) as diagnosed by the global initiative for chronic obstructive lung disease (gold) guidelines (2006).
    Beskrivning

    copd

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    4. patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and week 1.
    Beskrivning

    emergency room or hospitalization for asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0583237 (Emergency room admission)
    SNOMED
    50849002
    UMLS CUI [1,2]
    C0347950 (Asthma attack)
    SNOMED
    708038006
    UMLS CUI [2,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [2,2]
    C0347950 (Asthma attack)
    SNOMED
    708038006
    5. patients with diabetes type i or those with uncontrolled diabetes type ii including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (hba1c) > 8.0% measured at screening.
    Beskrivning

    diabetes mellitus

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [2]
    C0202042 (Plasma Glucose Measurement)
    SNOMED
    72191006
    UMLS CUI [3]
    C0019018 (Glycosylated hemoglobin A)
    LOINC
    LP16413-4
    6. patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
    Beskrivning

    comorbidity limiting study protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    7. patients with a history of long qt syndrome, or whose qtc interval (bazett's formula) is prolonged to > 450 ms (males) or > 470 ms (females).
    Beskrivning

    long qt syndrome or whose qtc interval (bazett's formula) is prolonged

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023976 (Long QT Syndrome)
    SNOMED
    9651007
    UMLS CUI [2]
    C0151878 (Prolonged QT interval)
    SNOMED
    111975006
    8. certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period.
    Beskrivning

    asthma medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    other protocol-defined inclusion/exclusion criteria applied to the study.
    Beskrivning

    criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0242801 (Selection Criteria)
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    Similar models

    Eligibility Asthma NCT00529529

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00529529
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age and informed consent
    Item
    1. male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or institutional review board/independent ethics committee/research ethics board [irb/iec/reb] approval) who have signed an informed consent form.
    boolean
    C0001779 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    moderate to severe persistent asthma
    Item
    2. patients with moderate to severe persistent asthma, diagnosed according to the global initiative for asthma (gina) guidelines (updated 2006) and who additionally meet the following criteria:
    boolean
    C1960047 (UMLS CUI [1])
    C1960048 (UMLS CUI [2])
    bronchodilator and beclomethasone dipropionate
    Item
    patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening.
    boolean
    C0006280 (UMLS CUI [1])
    C0004906 (UMLS CUI [2,1])
    C2348070 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [3])
    fev1
    Item
    patients whose forced expiratory volume in 1 second (fev1) is ≥ 50% of the predicted normal value.
    boolean
    C0748133 (UMLS CUI [1])
    fev1 post-bronchodilator
    Item
    patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in fev1, after inhaling 200
    boolean
    C0748133 (UMLS CUI [1,1])
    C2599594 (UMLS CUI [1,2])
    salbutamol
    Item
    μg salbutamol.
    boolean
    C0001927 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
    Item
    1. pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3])
    C0700589 (UMLS CUI [4])
    C0232970 (UMLS CUI [5])
    smoking history
    Item
    2. patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years.
    boolean
    C1519384 (UMLS CUI [1])
    C1277691 (UMLS CUI [2])
    copd
    Item
    3. patients who suffer from chronic obstructive pulmonary disease (copd) as diagnosed by the global initiative for chronic obstructive lung disease (gold) guidelines (2006).
    boolean
    C0024117 (UMLS CUI [1])
    emergency room or hospitalization for asthma
    Item
    4. patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and week 1.
    boolean
    C0583237 (UMLS CUI [1,1])
    C0347950 (UMLS CUI [1,2])
    C0019993 (UMLS CUI [2,1])
    C0347950 (UMLS CUI [2,2])
    diabetes mellitus
    Item
    5. patients with diabetes type i or those with uncontrolled diabetes type ii including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (hba1c) > 8.0% measured at screening.
    boolean
    C0011849 (UMLS CUI [1])
    C0202042 (UMLS CUI [2])
    C0019018 (UMLS CUI [3])
    comorbidity limiting study protocol
    Item
    6. patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
    boolean
    C2348563 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    long qt syndrome or whose qtc interval (bazett's formula) is prolonged
    Item
    7. patients with a history of long qt syndrome, or whose qtc interval (bazett's formula) is prolonged to > 450 ms (males) or > 470 ms (females).
    boolean
    C0023976 (UMLS CUI [1])
    C0151878 (UMLS CUI [2])
    asthma medication
    Item
    8. certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    criteria
    Item
    other protocol-defined inclusion/exclusion criteria applied to the study.
    boolean
    C0242801 (UMLS CUI [1])
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