0 Évaluations
ID

24594

Description

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

Mots-clés

Versions (3)
  1. 27/07/2017 27/07/2017 -
  2. 27/07/2017 27/07/2017 -
  3. 08/08/2017 08/08/2017 -
Téléchargé le

8 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    Anglais

    visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    subject identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    date of visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303
    CURRENT TOBACCO USE
    Description

    CURRENT TOBACCO USE

    Alias
    UMLS CUI-1
    C0543414
    Has the subject smoked/used tobacco since the last visit?
    Description

    use of tobacco since last visit

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1517741
    BASELINE DYSPNOEA INDEX (BDI)
    Description

    BASELINE DYSPNOEA INDEX (BDI)

    Alias
    UMLS CUI-1
    C1511069
    OROPHARYNGEAL CANDIDIASIS EXAMINATION
    Description

    OROPHARYNGEAL CANDIDIASIS EXAMINATION

    Alias
    UMLS CUI-1
    C0006849
    UMLS CUI-2
    C0582103
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Description

    clinical evidence of oropharyngeal candidiasis

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C3887511
    Was a swab taken?
    Description

    Swab need only be taken if there is clinical evidence of oropharyngeal candidiasis

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C0563454
    if a swab was taken, result of the swab?
    Description

    oropharyngeal candidiasis test result

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C0563454
    UMLS CUI [1,3]
    C1274040
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Blood pressure
    Description

    Position: sitting.

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Description

    heart rate

    Type de données

    integer

    Unités de mesure
    • beats/minute
    Alias
    UMLS CUI [1]
    C0018810
    beats/minute
    PULMONARY FUNCTION TESTING
    Description

    PULMONARY FUNCTION TESTING

    Alias
    UMLS CUI-1
    C0024119
    Has the subject taken VENTOLIN in the last 6 hours?
    Description

    ventolin taken in the last hours

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C1632850
    pulmonary funtion testing: FEV1
    Description

    pulmonary funtion testing: FEV1

    Alias
    UMLS CUI-1
    C0748133
    Time of Assessment PreVENTOLIN
    Description

    time of assessment before Ventolin

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0220825
    Actual Measurement PreVENTOLIN
    Description

    Actual Measurement PreVENTOLIN = A

    Type de données

    float

    Unités de mesure
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    pulmonary function testing: FVC
    Description

    pulmonary function testing: FVC

    Alias
    UMLS CUI-1
    C3714541
    Actual Measurement PreVENTOLIN
    Description

    Actual Measurement PreVENTOLIN = A

    Type de données

    float

    Unités de mesure
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    pulmonary function testing: FEV1 /FVC ratio
    Description

    pulmonary function testing: FEV1 /FVC ratio

    Alias
    UMLS CUI-1
    C0429745
    Actual Measurement PreVENTOLIN
    Description

    Actual Measurement PreVENTOLIN = A

    Type de données

    float

    Unités de mesure
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
    Description

    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

    Alias
    UMLS CUI-1
    C0451500
    Confirm the SGRQ has been completed by the subject
    Description

    SGRQ completed

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0451500
    UMLS CUI [1,2]
    C0205197
    EQ-5D (Euroqol)
    Description

    EQ-5D (Euroqol)

    Alias
    UMLS CUI-1
    C2733251
    Confirm the EQ-5D has been completed by the subject.
    Description

    EQ-5D completed

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2733251
    UMLS CUI [1,2]
    C0205197
    RANDOMISATION NUMBER
    Description

    RANDOMISATION NUMBER

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0237753
    Record randomisation number.
    Description

    randomisation number

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    INVESTIGATIONAL PRODUCT CONTAINER NUMBER
    Description

    INVESTIGATIONAL PRODUCT CONTAINER NUMBER

    Alias
    UMLS CUI-1
    C3898691
    UMLS CUI-2
    C0449788
    Record the identifying number from the investigational product container dispensed at this visit.
    Description

    investigational product containernumber

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C3898691
    UMLS CUI [1,2]
    C0449788
    TRANSITION DYSPNOEA INDEX (TDI)
    Description

    TRANSITION DYSPNOEA INDEX (TDI)

    Alias
    UMLS CUI-1
    C3714807
    Retour au début de la page

    Similar models

    visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    date of visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    CURRENT TOBACCO USE
    C0543414 (UMLS CUI-1)
    Item
    Has the subject smoked/used tobacco since the last visit?
    text
    C0543414 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    use of tobacco since last visit
    Code List
    Has the subject smoked/used tobacco since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    BASELINE DYSPNOEA INDEX (BDI)
    C1511069 (UMLS CUI-1)
    Item Group
    OROPHARYNGEAL CANDIDIASIS EXAMINATION
    C0006849 (UMLS CUI-1)
    C0582103 (UMLS CUI-2)
    Item
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    text
    C0006849 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    clinical evidence of oropharyngeal candidiasis
    Code List
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was a swab taken?
    text
    C0006849 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    taking of a swab
    Code List
    Was a swab taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    if a swab was taken, result of the swab?
    integer
    C0006849 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    oropharyngeal candidiasis test result
    Code List
    if a swab was taken, result of the swab?
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not available (4)
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    blood pressure
    Item
    Blood pressure
    integer
    C0005823 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    PULMONARY FUNCTION TESTING
    C0024119 (UMLS CUI-1)
    Item
    Has the subject taken VENTOLIN in the last 6 hours?
    text
    C0033744 (UMLS CUI [1,1])
    C1632850 (UMLS CUI [1,2])
    use of bronchodilatators before lung function measurement
    Code List
    Has the subject taken VENTOLIN in the last 6 hours?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    pulmonary funtion testing: FEV1
    C0748133 (UMLS CUI-1)
    time of assessment before Ventolin
    Item
    Time of Assessment PreVENTOLIN
    time
    C0033744 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item Group
    pulmonary function testing: FVC
    C3714541 (UMLS CUI-1)
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item Group
    pulmonary function testing: FEV1 /FVC ratio
    C0429745 (UMLS CUI-1)
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item Group
    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
    C0451500 (UMLS CUI-1)
    SGRQ completed
    Item
    Confirm the SGRQ has been completed by the subject
    boolean
    C0451500 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item Group
    EQ-5D (Euroqol)
    C2733251 (UMLS CUI-1)
    EQ-5D completed
    Item
    Confirm the EQ-5D has been completed by the subject.
    boolean
    C2733251 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item Group
    RANDOMISATION NUMBER
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    randomisation number
    Item
    Record randomisation number.
    float
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    INVESTIGATIONAL PRODUCT CONTAINER NUMBER
    C3898691 (UMLS CUI-1)
    C0449788 (UMLS CUI-2)
    investigational product containernumber
    Item
    Record the identifying number from the investigational product container dispensed at this visit.
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    TRANSITION DYSPNOEA INDEX (TDI)
    C3714807 (UMLS CUI-1)
    Retour au début de la page 

    Aide

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial