ID

32978

Descripción

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 Investigator Comment Log and Investigator’s Statement form. It has to be filled in at the end of study (after all relevant CRF pages, including outstanding test results, are completed).

Palabras clave

Versiones (3)
  1. 22/11/18 22/11/18 -
  2. 22/11/18 22/11/18 -
  3. 23/11/18 23/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de noviembre de 2018

DOI

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Licencia

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

Inglés

Investigator Comment Log, Investigator’s Statement

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Session Number
Descripción

Session Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Investigator Comment Log
Descripción

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of comment
Descripción

Date of comment

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
CRF page number if applicable
Descripción

CRF page number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Investigator’s Statement
Descripción

Investigator’s Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Confirmation
Descripción

I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0750484
Date
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Investigator’s signature
Descripción

Investigator’s signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name - print
Descripción

Investigator’s name - print

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Investigator Comment Log, Investigator’s Statement

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator’s Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Confirmation
Item
Confirmation
boolean
C0750484 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s name - print
Item
Investigator’s name - print
text
C2826892 (UMLS CUI [1])
Volver a la parte superior de la página 

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