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ID

41561

Description

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 (COPD and Smoking History) is to be filled out during the study.

Lien

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

Mots-clés

Versions (1)
  1. 11/11/20 11/11/20 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 novembre 2020

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    COPD and Smoking History

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

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

    Subject identification number

    Type de données

    text

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

    Date of visit/assessment

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Duration of COPD
    Description

    Duration of COPD

    Alias
    UMLS CUI-1
    C0872146 (disease length)
    UMLS CUI-2
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    Duration in years
    Description

    This item is optional

    Type de données

    integer

    Unités de mesure
    • years
    Alias
    UMLS CUI [1,1]
    C0872146 (disease length)
    UMLS CUI [1,2]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    years
    Duration in months
    Description

    This item is optional

    Type de données

    integer

    Unités de mesure
    • months
    Alias
    UMLS CUI [1,1]
    C0872146 (disease length)
    UMLS CUI [1,2]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    months
    History of COPD Exacerbations
    Description

    History of COPD Exacerbations

    Alias
    UMLS CUI-1
    C0740304 (COPD exacerbation)
    UMLS CUI-2
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    Number of exacerbations in the last [12 months] that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    Description

    If none, enter 0 (zero) 'oral corticosteroids', 'systemic corticosteroids', 'corticosteroids' and/or 'antibiotics' are all acceptable options

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0332185 (Recent)
    SNOMED
    6493001
    UMLS CUI [1,2]
    C0740304 (COPD exacerbation)
    UMLS CUI [1,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,4]
    C2825233 (systemic steroids)
    UMLS CUI [1,5]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,6]
    C1611645 (Not Required)
    UMLS CUI [2,1]
    C0332185 (Recent)
    SNOMED
    6493001
    UMLS CUI [2,2]
    C0740304 (COPD exacerbation)
    UMLS CUI [2,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [2,4]
    C0574135 (Oral steroid therapy)
    SNOMED
    297280007
    UMLS CUI [2,5]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [2,6]
    C1611645 (Not Required)
    UMLS CUI [3,1]
    C0332185 (Recent)
    SNOMED
    6493001
    UMLS CUI [3,2]
    C0740304 (COPD exacerbation)
    UMLS CUI [3,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [3,4]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    UMLS CUI [3,5]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [3,6]
    C1611645 (Not Required)
    Number of exacerbations in the last [12 months] that required hospitalisation.
    Description

    If none, enter 0 (zero)

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0332185 (Recent)
    SNOMED
    6493001
    UMLS CUI [1,2]
    C0740304 (COPD exacerbation)
    UMLS CUI [1,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,4]
    C1708385 (Hospitalization Required)
    COPD type
    Description

    COPD type

    Alias
    UMLS CUI-1
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    UMLS CUI-2
    C0332307 (Type - attribute)
    SNOMED
    261664005
    COPD type: chronic bronchitis
    Description

    Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0008677 (Bronchitis, Chronic)
    SNOMED
    63480004
    UMLS CUI [1,2]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    COPD type: Emphysema
    Description

    Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    UMLS CUI [1,2]
    C0034067 (Pulmonary Emphysema)
    SNOMED
    87433001
    LOINC
    LA10561-1
    Smoking History
    Description

    Smoking History

    Alias
    UMLS CUI-1
    C1519384 (Tobacco Smoking History)
    What is the subject's history of tobacco use?
    Description

    History of tobacco use

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0841002 (History of tobacco use)
    Average number of cigarettes smoked per pay
    Description

    Average number of cigarettes per day

    Type de données

    integer

    Unités de mesure
    • cigarettes per day
    Alias
    UMLS CUI [1,1]
    C3694146 (number of cigarettes per day)
    UMLS CUI [1,2]
    C1510992 (Average)
    LOINC
    LA14989-0
    cigarettes per day
    Number of years the subject has smoked
    Description

    Years smoked

    Type de données

    integer

    Unités de mesure
    • years
    Alias
    UMLS CUI [1]
    C3694955 (current smoker duration (___ years))
    years
    Number of pack years
    Description

    This item will be calculated by InForm using the following formula: Average number of cigarettes smoked per day divided by 20 and then multiplied by number of years smoked. Round up/down to nearest integer.

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1277691 (Pack years)
    SNOMED
    315609007
    Substance Use Type
    Description

    [hidden] This item will be calculated by InForm

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0439861 (Substance)
    SNOMED
    105590001
    LOINC
    LP20778-4
    UMLS CUI [1,2]
    C1524063 (Use of)
    SNOMED
    260676000
    UMLS CUI [1,3]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Retour au début de la page

    Similar models

    COPD and Smoking History

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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
    Duration of COPD
    C0872146 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    COPD Duration
    Item
    Duration in years
    integer
    C0872146 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    COPD Duration
    Item
    Duration in months
    integer
    C0872146 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    Item Group
    History of COPD Exacerbations
    C0740304 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Number of recent COPD exacerbations requiring corticosteroids (oral/systemic) and/or antibiotics, not involving hospitalisation
    Item
    Number of exacerbations in the last [12 months] that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    integer
    C0332185 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    C2825233 (UMLS CUI [1,4])
    C0019993 (UMLS CUI [1,5])
    C1611645 (UMLS CUI [1,6])
    C0332185 (UMLS CUI [2,1])
    C0740304 (UMLS CUI [2,2])
    C0449788 (UMLS CUI [2,3])
    C0574135 (UMLS CUI [2,4])
    C0019993 (UMLS CUI [2,5])
    C1611645 (UMLS CUI [2,6])
    C0332185 (UMLS CUI [3,1])
    C0740304 (UMLS CUI [3,2])
    C0449788 (UMLS CUI [3,3])
    C0003232 (UMLS CUI [3,4])
    C0019993 (UMLS CUI [3,5])
    C1611645 (UMLS CUI [3,6])
    Number of recent COPD exacerbations requiring hospitalisation
    Item
    Number of exacerbations in the last [12 months] that required hospitalisation.
    integer
    C0332185 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    C1708385 (UMLS CUI [1,4])
    Item Group
    COPD type
    C0024117 (UMLS CUI-1)
    C0332307 (UMLS CUI-2)
    COPD type chronic bronchitis
    Item
    COPD type: chronic bronchitis
    boolean
    C0008677 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    COPD type Emphysema
    Item
    COPD type: Emphysema
    boolean
    C0024117 (UMLS CUI [1,1])
    C0034067 (UMLS CUI [1,2])
    Item Group
    Smoking History
    C1519384 (UMLS CUI-1)
    Item
    What is the subject's history of tobacco use?
    integer
    C0841002 (UMLS CUI [1])
    History of tobacco use
    Code List
    What is the subject's history of tobacco use?
    CL Item
    Current smoker (2)
    CL Item
    Former smoker (3)
    Average number of cigarettes per day
    Item
    Average number of cigarettes smoked per pay
    integer
    C3694146 (UMLS CUI [1,1])
    C1510992 (UMLS CUI [1,2])
    Years smoked
    Item
    Number of years the subject has smoked
    integer
    C3694955 (UMLS CUI [1])
    Number of pack years
    Item
    Number of pack years
    integer
    C1277691 (UMLS CUI [1])
    Substance Use Type
    Item
    Substance Use Type
    text
    C0439861 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Retour au début de la page 

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