ID

33026

Beschreibung

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.

Stichworte

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  1. 22.11.18 22.11.18 -
  2. 23.11.18 23.11.18 -
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GlaxoSmithKline

Hochgeladen am

23. November 2018

DOI

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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

    Englisch

    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschreibung

    Subject number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Screening, Treatment Period Number, Follow up
    Beschreibung

    Screening, Treatment Period Number, Follow up

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0220908
    UMLS CUI [2,1]
    C0237753
    UMLS CUI [2,2]
    C1948053
    UMLS CUI [3]
    C1522577
    Compliance Restrictions
    Beschreibung

    Compliance Restrictions

    Alias
    UMLS CUI-1
    C1321605
    UMLS CUI-2
    C2065135
    Date of Assessment
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
    Beschreibung

    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.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C2065135
    Is the subject aware of any forthcoming requirements?
    Beschreibung

    Aware of forthcoming requirements

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    Comments to compliance
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1321605
    Concomitant Medications and Adverse Event Enquiry
    Beschreibung

    Concomitant Medications and Adverse Event Enquiry

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C1519255
    Has the subject used any concomitant medications?
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2347852
    Has there been any change in the state of the subject's health?
    Beschreibung

    If YES record any adverse events as per protocol.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0018759
    UMLS CUI [1,2]
    C0392747
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    Ähnliche Modelle

    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
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