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ID

41562

Beskrivning

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Medical Conditions) is to be filled out during the study. Record medical history for current conditions only.

Länk

https://clinicaltrials.gov/ct2/show/NCT00784550

Nyckelord

Versioner (1)
  1. 2020-11-11 2020-11-11 -
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GlaxoSmithKline

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11 november 2020

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Creative Commons BY-NC 4.0
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    Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

    Engelsk

    Medical Conditions

    1 Formulär  
    1. StudyEvent: ODM
      1. Medical Conditions
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identification number
    Beskrivning

    Subject identification number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit/assessment
    Beskrivning

    Date of visit/assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Medical Conditions
    Beskrivning

    Medical Conditions

    Alias
    UMLS CUI-1
    C0262926
    Blood and lymphatic system disorders
    Beskrivning

    Blood and lymphatic system disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0851353
    Cardiac disorders
    Beskrivning

    Cardiac disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0018799
    Ear and labyrinth disorders
    Beskrivning

    Ear and labyrinth disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0851354
    Endocrine disorders
    Beskrivning

    Endocrine disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0014130
    Eye disorders
    Beskrivning

    Eye disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0015397
    Gastrointestinal disorders
    Beskrivning

    Gastrointestinal disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0017178
    Hepatobiliary disorders
    Beskrivning

    Hepatobiliary disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0267792
    Immune system disorders
    Beskrivning

    Immune system disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1334156
    Metabolism and nutrition disorders
    Beskrivning

    Metabolism and nutrition disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0851358
    Musculoskeletal and connective tissue disorders
    Beskrivning

    Musculoskeletal and connective tissue disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0263660
    Neoplasms benign, malignant and unspecified (including cysts and polyps)
    Beskrivning

    Neoplasms benign, malignant and unspecified (including cysts and polyps)

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1882062
    UMLS CUI [1,2]
    C0205183
    UMLS CUI [2]
    C0006826
    UMLS CUI [3,1]
    C0027651
    UMLS CUI [3,2]
    C0205370
    UMLS CUI [4]
    C0010709
    UMLS CUI [5]
    C0032584
    Nervous system disorders
    Beskrivning

    Nervous system disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0027765
    Psychiatric disorder
    Beskrivning

    Psychiatric disorder

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0004936
    Renal and urinary disorder
    Beskrivning

    Renal and urinary disorder

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0042075
    UMLS CUI [2]
    C0022658
    Reproductive system and breast disorders
    Beskrivning

    Reproductive system and breast disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0851366
    Respiratory, thoracic and mediastinal disorders
    Beskrivning

    Respiratory, thoracic and mediastinal disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0851355
    Skin and subcutaneous tissue disorders
    Beskrivning

    Skin and subcutaneous tissue disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0178298
    Vascular disorders
    Beskrivning

    Vascular disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0042373
    Infections and infestations
    Beskrivning

    Infections and infestations

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0851341
    Congenital, familial and genetic disorders
    Beskrivning

    Congenital, familial and genetic disorders

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0851352
    Injury, poisoning and procedural complications
    Beskrivning

    Injury, poisoning and procedural complications

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0947733
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    Similar models

    Medical Conditions

    1 Formulär
    1. StudyEvent: ODM
      1. Medical Conditions
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject identification number
    Item
    Subject identification number
    text
    C2348585 (UMLS CUI [1])
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item Group
    Medical Conditions
    C0262926 (UMLS CUI-1)
    Item
    Blood and lymphatic system disorders
    integer
    C0851353 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Blood and lymphatic system disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Cardiac disorders
    integer
    C0018799 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Cardiac disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Ear and labyrinth disorders
    integer
    C0851354 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Ear and labyrinth disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Endocrine disorders
    integer
    C0014130 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Endocrine disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Eye disorders
    integer
    C0015397 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Eye disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Gastrointestinal disorders
    integer
    C0017178 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Gastrointestinal disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Hepatobiliary disorders
    integer
    C0267792 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Hepatobiliary disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Immune system disorders
    integer
    C1334156 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Immune system disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Metabolism and nutrition disorders
    integer
    C0851358 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Metabolism and nutrition disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Musculoskeletal and connective tissue disorders
    integer
    C0263660 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Musculoskeletal and connective tissue disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Neoplasms benign, malignant and unspecified (including cysts and polyps)
    integer
    C1882062 (UMLS CUI [1,1])
    C0205183 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [2])
    C0027651 (UMLS CUI [3,1])
    C0205370 (UMLS CUI [3,2])
    C0010709 (UMLS CUI [4])
    C0032584 (UMLS CUI [5])
    Blood and lymphatic system disorders
    Code List
    Neoplasms benign, malignant and unspecified (including cysts and polyps)
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Nervous system disorders
    integer
    C0027765 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Nervous system disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Psychiatric disorder
    integer
    C0004936 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Psychiatric disorder
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Renal and urinary disorder
    integer
    C0042075 (UMLS CUI [1])
    C0022658 (UMLS CUI [2])
    Blood and lymphatic system disorders
    Code List
    Renal and urinary disorder
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Reproductive system and breast disorders
    integer
    C0851366 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Reproductive system and breast disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Respiratory, thoracic and mediastinal disorders
    integer
    C0851355 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Respiratory, thoracic and mediastinal disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Skin and subcutaneous tissue disorders
    integer
    C0178298 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Skin and subcutaneous tissue disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Vascular disorders
    integer
    C0042373 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Vascular disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Infections and infestations
    integer
    C0009450 (UMLS CUI [1])
    C0851341 (UMLS CUI [2])
    Blood and lymphatic system disorders
    Code List
    Infections and infestations
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Congenital, familial and genetic disorders
    integer
    C0851352 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Congenital, familial and genetic disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Item
    Injury, poisoning and procedural complications
    integer
    C0947733 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Injury, poisoning and procedural complications
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    Tillbaka till toppen 

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