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ID

14392

Description

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

Link

https://clinicaltrials.gov/show/NCT00529529

Keywords

Versions (1)
  1. 4/13/16 4/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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    Eligibility Asthma NCT00529529

    English

    Eligibility Asthma NCT00529529

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00529529
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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.
    Description

    age and informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0021430
    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:
    Description

    moderate to severe persistent asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960047
    UMLS CUI [2]
    C1960048
    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.
    Description

    bronchodilator and beclomethasone dipropionate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006280
    UMLS CUI [2,1]
    C0004906
    UMLS CUI [2,2]
    C2348070
    UMLS CUI [3]
    C0040223
    patients whose forced expiratory volume in 1 second (fev1) is ≥ 50% of the predicted normal value.
    Description

    fev1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0748133
    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
    Description

    fev1 post-bronchodilator

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C2599594
    μg salbutamol.
    Description

    salbutamol

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001927
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    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.
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C3831118
    UMLS CUI [4]
    C0700589
    UMLS CUI [5]
    C0232970
    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.
    Description

    smoking history

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519384
    UMLS CUI [2]
    C1277691
    3. patients who suffer from chronic obstructive pulmonary disease (copd) as diagnosed by the global initiative for chronic obstructive lung disease (gold) guidelines (2006).
    Description

    copd

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    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.
    Description

    emergency room or hospitalization for asthma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0583237
    UMLS CUI [1,2]
    C0347950
    UMLS CUI [2,1]
    C0019993
    UMLS CUI [2,2]
    C0347950
    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.
    Description

    diabetes mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    UMLS CUI [2]
    C0202042
    UMLS CUI [3]
    C0019018
    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.
    Description

    comorbidity limiting study protocol

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    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).
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023976
    UMLS CUI [2]
    C0151878
    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.
    Description

    asthma medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0004096
    UMLS CUI [1,3]
    C0040223
    other protocol-defined inclusion/exclusion criteria applied to the study.
    Description

    criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242801
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    Similar models

    Eligibility Asthma NCT00529529

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00529529
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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