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)
- 11/13/18 11/13/18 -
- 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
Informed consent, demography
- StudyEvent: ODM
Description
Informed consent
Alias
- UMLS CUI-1
- C0021430
Description
Written informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Investigator’s signature
Data type
text
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0021430
Description
Date of informed consent
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
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
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
float
Measurement units
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Demography for Females
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C0086287
Similar models
Informed consent, demography
- StudyEvent: ODM
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0086287 (UMLS CUI-2)
C0456984 (UMLS CUI [1,2])