ID

32965

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

Keywords

Versions (3)
  1. 11/13/18 11/13/18 -
  2. 11/16/18 11/16/18 -
  3. 11/22/18 11/22/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 22, 2018

DOI

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License

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

English

Medical history and training

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Description

Date of screening

Data type

date

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

Medical History

Alias
UMLS CUI-1
C0262926
Medical conditions
Description

Medical history, examinaton

Data type

integer

Alias
UMLS CUI [1]
C0012634
Medical condition status
Description

Medical condition status

Data type

text

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

Medical condition, present

Data type

text

Alias
UMLS CUI [1]
C0012634
Training
Description

Training

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

Accuhaler, MDI, spacer training

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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