ID
32973
Beschrijving
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 form for Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry. It has to be filled in for screening (only compliance restrictions), period 1-5 and for follow-up.
Trefwoorden
Versies (2)
- 22-11-18 22-11-18 -
- 23-11-18 23-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 november 2018
DOI
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Licentie
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
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry
Beschrijving
Compliance Restrictions
Alias
- UMLS CUI-1
- C1321605
- UMLS CUI-2
- C2065135
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Requirements compliance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C2065135
Beschrijving
Aware of forthcoming requirements
Datatype
text
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1321605
Beschrijving
Concomitant Medications and Adverse Event Enquiry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1519255
Beschrijving
If YES, record on CONCOMITANT MED/CATIONS page(s).
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
If YES record any adverse events as per protocol.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018759
- UMLS CUI [1,2]
- C0392747
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