ID

32961

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 physical examination form. It has to be filled in for screening and for periods 1-5.

Keywords

Versions (2)
  1. 11/16/18 11/16/18 -
  2. 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

Physical examination

1 forms  
  1. StudyEvent: ODM
    1. Physical examination
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Treatment Period/Session number
Description

Treatment Period/Session number

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1948053
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Description

Physical Examination, Systems

Data type

integer

Alias
UMLS CUI [1]
C0031809
Examination status
Description

"Not done" only applicable for: Breasts, Urogenital, Pelvic and Rectal.

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
If abnormal examination, please specify
Description

Abnormal examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0459424
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Similar models

Physical examination

1 forms
  1. StudyEvent: ODM
    1. Physical examination
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])
Item
Treatment Period/Session number
integer
C0237753 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Period/Session number
Code List
Treatment Period/Session number
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
Treatment Period 5 (6)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Physical Examination
integer
C0031809 (UMLS CUI [1])
Physical Examination, Systems
Code List
Physical Examination
CL Item
Hair and Skin  (1)
CL Item
Lymph nodes  (2)
CL Item
Eyes  (3)
CL Item
Ears, Nose and Throat  (4)
CL Item
Breasts  (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular  (7)
CL Item
Abdomen (8)
CL Item
Uro genital  (9)
CL Item
Pelvic  (10)
CL Item
Rectal  (11)
CL Item
M usculoskeletal (12)
CL Item
Neurological  (13)
CL Item
Mental Status (14)
Item
Examination status
text
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Examination status
Code List
Examination status
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Abnormal examination
Item
If abnormal examination, please specify
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
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