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ID

33026

Description

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form for Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry. It has to be filled in for screening (only compliance restrictions), period 1-5 and for follow-up.

Mots-clés

Versions (2)
  1. 22/11/2018 22/11/2018 -
  2. 23/11/2018 23/11/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

23 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

    Anglais

    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

    1 Formulaires  
    Administrative data
    Description

    Administrative data

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

    Subject number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Screening, Treatment Period Number, Follow up
    Description

    Screening, Treatment Period Number, Follow up

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [2,1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    UMLS CUI [2,2]
    C1948053 (Period (temporal qualifier))
    SNOMED
    272117007
    UMLS CUI [3]
    C1522577 (follow-up)
    Compliance Restrictions
    Description

    Compliance Restrictions

    Alias
    UMLS CUI-1
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI-2
    C2065135 (work restrictions)
    Date of Assessment
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
    Description

    Requirements of compliance: -The Investigator (or designated study physician) must be informed as soon as possible about any medication taken from the time of screening until the end of the clinical phase of the study (follow-up visit). -Subjects must refrain from strenuous exercise for 48 hours before the screening visit, each treatment period and follow-up visit. -Subjects must refrain from alcohol for 24 hours prior to each treatment period until discharge from the unit (on each respective treatment period). -Subjects must refrain from grapefruit or grapefruit juice containing products from 7 days pre-dose until discharge from the unit on each dosing occasion. -Subjects must refrain from foods or beverages containing caffeine from 24 hours prior to treatment periods until discharge from the unit (on each respective treatment period). -Subjects must refrain from all recreational drugs throughout the study (screening to follow-up). Drugs of abuse tests will be performed randomly throughout the study to check this. A confirmed positive result will lead to withdrawal from the study. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0525058 (Protocol Compliance)
    UMLS CUI [1,2]
    C2065135 (work restrictions)
    Is the subject aware of any forthcoming requirements?
    Description

    Aware of forthcoming requirements

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    Comments to compliance
    Description

    Comments

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    Concomitant Medications and Adverse Event Enquiry
    Description

    Concomitant Medications and Adverse Event Enquiry

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    UMLS CUI-2
    C1519255 (Serious Adverse Event)
    Has the subject used any concomitant medications?
    Description

    If YES, record on CONCOMITANT MED/CATIONS page(s).

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Has there been any change in the state of the subject's health?
    Description

    If YES record any adverse events as per protocol.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0018759 (Health Status)
    SNOMED
    406221003
    UMLS CUI [1,2]
    C0392747 (Changing)
    SNOMED
    18307000
    Retour au début de la page

    Similar models

    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Screening, Treatment Period Number, Follow up
    text
    C0220908 (UMLS CUI [1])
    C0237753 (UMLS CUI [2,1])
    C1948053 (UMLS CUI [2,2])
    C1522577 (UMLS CUI [3])
    Period Number
    Code List
    Screening, Treatment Period Number, Follow up
    CL Item
    Screening (1)
    CL Item
    Treatment Period 1 (2)
    CL Item
    Treatment Period 2 (3)
    CL Item
    Treatment Period 3 (4)
    CL Item
    Treatment Period 4 (5)
    CL Item
    Follow-up (FU)
    CL Item
    Treatment Period 5 (6)
    Item Group
    Compliance Restrictions
    C1321605 (UMLS CUI-1)
    C2065135 (UMLS CUI-2)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
    text
    C0525058 (UMLS CUI [1,1])
    C2065135 (UMLS CUI [1,2])
    Requirements compliance
    Code List
    Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Is the subject aware of any forthcoming requirements?
    text
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Aware of forthcoming requirements
    Code List
    Is the subject aware of any forthcoming requirements?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments to compliance
    text
    C0947611 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    Item Group
    Concomitant Medications and Adverse Event Enquiry
    C2347852 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Item
    Has the subject used any concomitant medications?
    text
    C2347852 (UMLS CUI [1])
    Concomitant medications
    Code List
    Has the subject used any concomitant medications?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Has there been any change in the state of the subject's health?
    text
    C0018759 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    Health state, change
    Code List
    Has there been any change in the state of the subject's health?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Retour au début de la page 

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