ID

32825

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

Stichworte

  1. 13.11.18 13.11.18 -
  2. 16.11.18 16.11.18 -
  3. 22.11.18 22.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. November 2018

DOI

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Lizenz

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

Medical history and training

Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Beschreibung

Date of screening

Datentyp

date

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

Medical History

Alias
UMLS CUI-1
C0262926
Medical conditions
Beschreibung

Medical history, examinaton

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C0348080
Medical condition status
Beschreibung

Medical condition status

Datentyp

text

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0449438
If you tick present, please specify
Beschreibung

Medical condition, present

Datentyp

text

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C0348080
Training
Beschreibung

Training

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

Accuhaler, MDI, spacer training

Datentyp

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

Ähnliche Modelle

Medical history and training

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])
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
C0205476 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
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
C0205476 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Code List
Medical condition status
CL Item
Present (P)
CL Item
Not present (NP)
Medical condition, present
Item
If you tick present, please specify
text
C0205476 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
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])
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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