0 Evaluaciones
ID

41562

Descripción

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.

Link

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

Palabras clave

Versiones (1)
  1. 11/11/20 11/11/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de noviembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

    Inglés

    Medical Conditions

    1 formularios  
    1. StudyEvent: ODM
      1. Medical Conditions
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject identification number
    Descripción

    Subject identification number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of visit/assessment
    Descripción

    Date of visit/assessment

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Medical Conditions
    Descripción

    Medical Conditions

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    Blood and lymphatic system disorders
    Descripción

    Blood and lymphatic system disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0851353 (Blood and lymphatic system disorders)
    Cardiac disorders
    Descripción

    Cardiac disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    Ear and labyrinth disorders
    Descripción

    Ear and labyrinth disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0851354 (Ear and labyrinth disorders)
    Endocrine disorders
    Descripción

    Endocrine disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0014130 (Endocrine System Diseases)
    SNOMED
    362969004
    Eye disorders
    Descripción

    Eye disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0015397 (Disorder of eye)
    SNOMED
    371405004
    Gastrointestinal disorders
    Descripción

    Gastrointestinal disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0017178 (Gastrointestinal Diseases)
    SNOMED
    25374005
    Hepatobiliary disorders
    Descripción

    Hepatobiliary disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0267792 (Hepatobiliary Disorder)
    Immune system disorders
    Descripción

    Immune system disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1334156 (Immune System and Related Disorders)
    Metabolism and nutrition disorders
    Descripción

    Metabolism and nutrition disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0851358 (Metabolism and nutrition disorders)
    Musculoskeletal and connective tissue disorders
    Descripción

    Musculoskeletal and connective tissue disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0263660 (Musculoskeletal and connective tissue disorders)
    SNOMED
    312225001
    Neoplasms benign, malignant and unspecified (including cysts and polyps)
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1882062 (Neoplastic disease)
    SNOMED
    55342001
    LOINC
    MTHU052369
    UMLS CUI [1,2]
    C0205183 (Benign)
    SNOMED
    30807003
    LOINC
    LA6675-8
    UMLS CUI [2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [3,1]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    UMLS CUI [3,2]
    C0205370 (Unspecified)
    SNOMED
    10003008
    LOINC
    LA14093-1
    UMLS CUI [4]
    C0010709 (Cyst)
    SNOMED
    441457006
    LOINC
    LP249802-2
    UMLS CUI [5]
    C0032584 (polyps)
    SNOMED
    441456002
    Nervous system disorders
    Descripción

    Nervous system disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    Psychiatric disorder
    Descripción

    Psychiatric disorder

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    Renal and urinary disorder
    Descripción

    Renal and urinary disorder

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0042075 (Urologic Diseases)
    SNOMED
    41368006
    UMLS CUI [2]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001
    Reproductive system and breast disorders
    Descripción

    Reproductive system and breast disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0851366 (reproductive system and breast disorders)
    Respiratory, thoracic and mediastinal disorders
    Descripción

    Respiratory, thoracic and mediastinal disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0851355 (Respiratory, thoracic and mediastinal disorders)
    Skin and subcutaneous tissue disorders
    Descripción

    Skin and subcutaneous tissue disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0178298 (Skin and subcutaneous tissue disorders)
    SNOMED
    80659006
    Vascular disorders
    Descripción

    Vascular disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0042373 (Vascular Diseases)
    SNOMED
    27550009
    Infections and infestations
    Descripción

    Infections and infestations

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [2]
    C0851341 (Infestation)
    Congenital, familial and genetic disorders
    Descripción

    Congenital, familial and genetic disorders

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0851352 (Congenital, familial and genetic disorders)
    Injury, poisoning and procedural complications
    Descripción

    Injury, poisoning and procedural complications

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0947733 (Injury, poisoning and procedural complications)
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    Similar models

    Medical Conditions

    1 formularios
    1. StudyEvent: ODM
      1. Medical Conditions
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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)
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