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ID

13559

Beskrivning

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01404013

Länk

https://clinicaltrials.gov/show/NCT01404013

Nyckelord

  1. 2016-02-15 2016-02-15 -
Uppladdad den

15 februari 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Asthma NCT01404013

    Eligibility Asthma NCT01404013

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01404013
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
    Beskrivning

    medical history Coughing

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0010200
    2. patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
    Beskrivning

    Inhalation bronchial challenge testing with methacholine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3526951
    3. there is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
    Beskrivning

    therapy Bronchodilator Agents

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0006280
    4. patients whose chest x-ray outcome was normal or without any active focus.
    Beskrivning

    chest x-ray

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0039985
    5. patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients demonstrate fev1/fvc <70% in lung function test. fev1 stands for forced expiratory volume in 1 second, fvc stands for forced vital capacity.
    Beskrivning

    FEV1/FVC percent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0730560
    2. patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
    Beskrivning

    Smoking Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    3. patients with concomitance of gerc (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, acei induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
    Beskrivning

    comorbidity; chronic bronchitis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0008677
    4. female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
    Beskrivning

    pregnancy; lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    5. subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
    Beskrivning

    hypersensitivity drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013227
    6. subjects who have received any therapy in the previous seven days, e.g. oral/
    Beskrivning

    Concomitant Therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1707479
    inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
    Beskrivning

    corticosteroid; Adrenergic beta-2 Receptor Agonists;

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2]
    C2936789
    UMLS CUI [3]
    C0039771
    7. subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
    Beskrivning

    study outcome limited comorbidity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0543472
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    8. subjects who demonstrate significant abnormality on biochemistry, hematology, ecg.
    Beskrivning

    biochemistry; hematology; Electrocardiogram

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005477
    UMLS CUI [2]
    C0018941
    UMLS CUI [3]
    C0013798

    Similar models

    Eligibility Asthma NCT01404013

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01404013
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    medical history Coughing
    Item
    1. patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0010200 (UMLS CUI [1,2])
    Inhalation bronchial challenge testing with methacholine
    Item
    2. patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
    boolean
    C3526951 (UMLS CUI [1])
    therapy Bronchodilator Agents
    Item
    3. there is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
    boolean
    C0087111 (UMLS CUI [1,1])
    C0006280 (UMLS CUI [1,2])
    chest x-ray
    Item
    4. patients whose chest x-ray outcome was normal or without any active focus.
    boolean
    C0039985 (UMLS CUI [1])
    age
    Item
    5. patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
    boolean
    C0001779 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    FEV1/FVC percent
    Item
    1. patients demonstrate fev1/fvc <70% in lung function test. fev1 stands for forced expiratory volume in 1 second, fvc stands for forced vital capacity.
    boolean
    C0730560 (UMLS CUI [1])
    Smoking Status
    Item
    2. patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
    boolean
    C1519386 (UMLS CUI [1])
    comorbidity; chronic bronchitis
    Item
    3. patients with concomitance of gerc (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, acei induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
    boolean
    C0009488 (UMLS CUI [1])
    C0008677 (UMLS CUI [2])
    pregnancy; lactating
    Item
    4. female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    hypersensitivity drugs
    Item
    5. subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Concomitant Therapy
    Item
    6. subjects who have received any therapy in the previous seven days, e.g. oral/
    boolean
    C1707479 (UMLS CUI [1])
    corticosteroid; Adrenergic beta-2 Receptor Agonists;
    Item
    inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
    boolean
    C0001617 (UMLS CUI [1])
    C2936789 (UMLS CUI [2])
    C0039771 (UMLS CUI [3])
    study outcome limited comorbidity
    Item
    7. subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
    boolean
    C0543472 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    biochemistry; hematology; Electrocardiogram
    Item
    8. subjects who demonstrate significant abnormality on biochemistry, hematology, ecg.
    boolean
    C0005477 (UMLS CUI [1])
    C0018941 (UMLS CUI [2])
    C0013798 (UMLS CUI [3])

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