ID

32965

Beskrivning

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 medical history and state of training of subject. It has to be filled in at screening.

Nyckelord

Versioner (3)
  1. 2018-11-13 2018-11-13 -
  2. 2018-11-16 2018-11-16 -
  3. 2018-11-22 2018-11-22 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 november 2018

DOI

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Licens

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

Engelsk

Medical history and training

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Beskrivning

Date of screening

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Medical History
Beskrivning

Medical History

Alias
UMLS CUI-1
C0262926
Medical conditions
Beskrivning

Medical history, examinaton

Datatyp

integer

Alias
UMLS CUI [1]
C0012634
Medical condition status
Beskrivning

Medical condition status

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
If you tick yes in "medical condition status", please specify
Beskrivning

Medical condition, present

Datatyp

text

Alias
UMLS CUI [1]
C0012634
Training
Beskrivning

Training

Alias
UMLS CUI-1
C0015259
Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
Beskrivning

Accuhaler, MDI, spacer training

Datatyp

text

Alias
UMLS CUI [1,1]
C0939246
UMLS CUI [1,2]
C0015259
UMLS CUI [2,1]
C0993596
UMLS CUI [2,2]
C0015259
UMLS CUI [3,1]
C0592626
UMLS CUI [3,2]
C0015259
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Similar models

Medical history and training

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of screening
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Medical History
C0262926 (UMLS CUI-1)
Item
Medical conditions
integer
C0012634 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Medical conditions
CL Item
Ear, Nose and Throat  (1)
CL Item
Eyes  (2)
CL Item
Respiratory (3)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal  (5)
CL Item
Hepatobiliary and pancreas (6)
CL Item
Urology (7)
CL Item
Reproduction (8)
CL Item
Neurology  (9)
CL Item
Blood and lymphatic (10)
CL Item
Endocrine and metabolic (11)
CL Item
Musculoskeletal (12)
CL Item
Skin  (13)
CL Item
Psychiatry  (14)
CL Item
Allergies (15)
Item
Medical condition status
text
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Ear, Nose and Throat
Code List
Medical condition status
CL Item
Yes (Y)
CL Item
No (N)
Medical condition, present
Item
If you tick yes in "medical condition status", please specify
text
C0012634 (UMLS CUI [1])
Item Group
Training
C0015259 (UMLS CUI-1)
Item
Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
text
C0939246 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0993596 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0592626 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
Accuhaler, MDI, spacer training
Code List
Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
CL Item
No (N)
CL Item
Yes (Y)
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