ID

32828

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 informed consent form and demography of subject. It has to be filled in for Session 1.

Keywords

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

GlaxoSmithKline

Uploaded on

November 16, 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

Informed consent, demography

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 assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Investigator Number
Description

Investigator Number

Data type

text

Alias
UMLS CUI [1]
C2826689
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
I confirm that written informed consent has been obtained from the subject, prior to admission into the study.
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Investigator’s signature
Description

Investigator’s signature

Data type

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0021430
Date of informed consent
Description

Date of informed consent

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

W: Origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa. B: Origins in any of the black racial groups of Africa. A:Origins in the original peoples of the Indian subcontinent, the Far East, Southeast Asia, or the Pacific islands. X:People whose racial group is not represented above, or whose predominant origin cannot be determined.

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Demography for Females
Description

Demography for Females

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0086287
Childbearing potential
Description

Please tick one

Data type

integer

Alias
UMLS CUI [1]
C3831118
Pregnancy test result
Description

Please tick one

Data type

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0456984
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Similar models

Informed consent, demography

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 assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Investigator Number
Item
Investigator Number
text
C2826689 (UMLS CUI [1])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Written informed consent
Item
I confirm that written informed consent has been obtained from the subject, prior to admission into the study.
boolean
C0021430 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White  (W)
CL Item
Black (B)
CL Item
asian (A)
CL Item
Other (X)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Demography for Females
C0011298 (UMLS CUI-1)
C0086287 (UMLS CUI-2)
Item
Childbearing potential
integer
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
Childbearing potential
CL Item
Premenarcheal (1)
CL Item
Sterile (of childbearing age) (2)
CL Item
Postmenopausal (3)
CL Item
Potentially able to conceive children (4)
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)
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