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ID

24607

Descrição

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

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Versões (3)
  1. 06/08/2017 06/08/2017 -
  2. 08/08/2017 08/08/2017 -
  3. 08/08/2017 08/08/2017 -
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8 de agosto de 2017

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Creative Commons BY-NC 3.0
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    concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    Inglês

    concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulários  
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrição

    subject identifier

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    COPD CONCOMITANT MEDICATIONS
    Descrição

    COPD CONCOMITANT MEDICATIONS

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0024117
    Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
    Descrição

    COPD concomitant medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0024117
    If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
    Descrição

    If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0024117
    Drug Name
    Descrição

    Trade name preferred.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2360065
    Unit Dose
    Descrição

    unit dose

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0869039
    Unit
    Descrição

    units of medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Descrição

    frequency of medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Descrição

    medication routes

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Descrição

    start date of medication

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Taken prior to study?
    Descrição

    medication taken prior to study

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826667
    Stop Date
    Descrição

    stop date of medication

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Ongoing medication?
    Descrição

    concomitant medication ongoing

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826666
    Was drug administered for an exacerbation?
    Descrição

    drug adminstered for a COPD exacerbation

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0740304
    NON-COPD CONCOMITANT MEDICATIONS
    Descrição

    NON-COPD CONCOMITANT MEDICATIONS

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Descrição

    medication that is not COPD-related

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2347852
    If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
    Descrição

    If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.

    Alias
    UMLS CUI-1
    C2347852
    Drug name
    Descrição

    Trade name preferred.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2360065
    Unit Dose
    Descrição

    unit dose

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0869039
    Unit
    Descrição

    units of medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Descrição

    frequency of medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Descrição

    medication routes

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013153
    Reason for Medication
    Descrição

    reason for medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Start Date
    Descrição

    start date of medication

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Taken prior to study?
    Descrição

    medication taken prior to study

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826667
    Stop Date
    Descrição

    stop date of medication

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Ongoing medication?
    Descrição

    concomitant medication ongoing

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826666
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    Similar models

    concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    COPD CONCOMITANT MEDICATIONS
    C2347852 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    Item
    Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
    text
    C2347852 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    COPD concomitant medication
    Code List
    Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
    C2347852 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    medication name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    unit dose
    Item
    Unit Dose
    integer
    C0869039 (UMLS CUI [1])
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    units of medication
    Code List
    Unit
    CL Item
    Actuation (ACTU)
    CL Item
    Ampoule  (AMP)
    CL Item
    Application  (APP)
    CL Item
    Bottle  (BOT)
    CL Item
    Cubic centimeter (CC)
    CL Item
    Capsule (CAP)
    CL Item
    Gram (G)
    CL Item
    Drops  (GTT)
    CL Item
    International Units (IU)
    CL Item
    Litre (L)
    CL Item
    Litres per minute (L/MIN)
    CL Item
    Lozenge (LOZ)
    CL Item
    Microgram (MCG)
    CL Item
    Microgram per kilogram per minute (MCG/KG/MIN)
    CL Item
    Microlitre (MCL)
    CL Item
    Millimole (MMOL)
    CL Item
    Nebule (NEB)
    CL Item
    Puff (PUFF)
    CL Item
    Spray (SPR)
    CL Item
    Tablet (TAB)
    CL Item
    Tablespoon (TBLSP)
    CL Item
    Teaspoon (TSP)
    CL Item
    Percent (%)
    CL Item
    Unknown (UNK)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    frequency of medication
    Code List
    Frequency
    CL Item
    1 X daily (OD/QD)
    CL Item
    2 X daily (BID)
    CL Item
    3 X daily (TID)
    CL Item
    4 X daily  (QID)
    CL Item
    Continuous (CONT)
    CL Item
    Cumulative dose (CUM)
    CL Item
    Daily (D)
    CL Item
    Intermittent (INT)
    CL Item
    Not available (NA)
    CL Item
    At night (NOCT)
    CL Item
    Other (OTH)
    CL Item
    As required (PRN)
    CL Item
    Every hour (quaque hora) (QH)
    CL Item
    Every other day (QOD)
    CL Item
    Every night (quaque nocte) (QN)
    CL Item
    Single dose (SD)
    CL Item
    Immediately (STAT)
    CL Item
    Taper (TAP)
    CL Item
    Unknown (UNK)
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    medication routes
    Code List
    Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intranasal (IN)
    CL Item
    Injection (INJ)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Other (OTH)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous (SC)
    CL Item
    Topical (TP)
    CL Item
    Unknown (UNK)
    start date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Taken prior to study?
    text
    C2826667 (UMLS CUI [1])
    medication taken prior to study
    Code List
    Taken prior to study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    stop date of medication
    Item
    Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Ongoing medication?
    text
    C2826666 (UMLS CUI [1])
    concomitant medication ongoing
    Code List
    Ongoing medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was drug administered for an exacerbation?
    text
    C3469597 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    drug adminstered for a COPD exacerbation
    Code List
    Was drug administered for an exacerbation?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    NON-COPD CONCOMITANT MEDICATIONS
    C2347852 (UMLS CUI-1)
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    text
    C2347852 (UMLS CUI [1])
    concomitant medication
    Code List
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
    C2347852 (UMLS CUI-1)
    medication name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1])
    unit dose
    Item
    Unit Dose
    integer
    C0869039 (UMLS CUI [1])
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    units of medication
    Code List
    Unit
    CL Item
    Actuation (ACTU)
    CL Item
    Ampoule  (AMP)
    CL Item
    Application  (APP)
    CL Item
    Bottle  (BOT)
    CL Item
    Cubic centimeter (CC)
    CL Item
    Capsule (CAP)
    CL Item
    Gram (G)
    CL Item
    Drops  (GTT)
    CL Item
    International Units (IU)
    CL Item
    Litre (L)
    CL Item
    Litres per minute (L/MIN)
    CL Item
    Lozenge (LOZ)
    CL Item
    Microgram (MCG)
    CL Item
    Microgram per kilogram per minute (MCG/KG/MIN)
    CL Item
    Microlitre (MCL)
    CL Item
    Millimole (MMOL)
    CL Item
    Nebule (NEB)
    CL Item
    Puff (PUFF)
    CL Item
    Spray (SPR)
    CL Item
    Tablet (TAB)
    CL Item
    Tablespoon (TBLSP)
    CL Item
    Teaspoon (TSP)
    CL Item
    Percent (%)
    CL Item
    Unknown (UNK)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    frequency of medication
    Code List
    Frequency
    CL Item
    1 X daily (OD/QD)
    CL Item
    2 X daily (BID)
    CL Item
    3 X daily (TID)
    CL Item
    4 X daily  (QID)
    CL Item
    Continuous (CONT)
    CL Item
    Cumulative dose (CUM)
    CL Item
    Daily (D)
    CL Item
    Intermittent (INT)
    CL Item
    Not available (NA)
    CL Item
    At night (NOCT)
    CL Item
    Other (OTH)
    CL Item
    As required (PRN)
    CL Item
    Every hour (quaque hora) (QH)
    CL Item
    Every other day (QOD)
    CL Item
    Every night (quaque nocte) (QN)
    CL Item
    Single dose (SD)
    CL Item
    Immediately (STAT)
    CL Item
    Taper (TAP)
    CL Item
    Unknown (UNK)
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    medication routes
    Code List
    Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intranasal (IN)
    CL Item
    Injection (INJ)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Other (OTH)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous (SC)
    CL Item
    Topical (TP)
    CL Item
    Unknown (UNK)
    reason for medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    start date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Taken prior to study?
    text
    C2826667 (UMLS CUI [1])
    medication taken prior to study
    Code List
    Taken prior to study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    stop date of medication
    Item
    Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Ongoing medication?
    text
    C2826666 (UMLS CUI [1])
    concomitant medication ongoing
    Code List
    Ongoing medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
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