ID

32961

Descrição

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.

Palavras-chave

  1. 16/11/2018 16/11/2018 -
  2. 22/11/2018 22/11/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

22 de novembro de 2018

DOI

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Licença

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

Physical examination

  1. StudyEvent: ODM
    1. Physical examination
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrição

Subject number

Tipo de dados

text

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

Treatment Period/Session number

Tipo de dados

integer

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

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Descrição

Physical Examination, Systems

Tipo de dados

integer

Alias
UMLS CUI [1]
C0031809
Examination status
Descrição

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

Tipo de dados

text

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

Abnormal examination

Tipo de dados

text

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

Similar models

Physical examination

  1. StudyEvent: ODM
    1. Physical examination
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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])
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])
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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