ID
32973
Beschreibung
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.
Stichworte
Versionen (2)
- 22.11.18 22.11.18 -
- 23.11.18 23.11.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
22. November 2018
DOI
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Lizenz
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
Beschreibung
Compliance Restrictions
Alias
- UMLS CUI-1
- C1321605
- UMLS CUI-2
- C2065135
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Requirements compliance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C2065135
Beschreibung
Aware of forthcoming requirements
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1321605
Beschreibung
Concomitant Medications and Adverse Event Enquiry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1519255
Beschreibung
If YES, record on CONCOMITANT MED/CATIONS page(s).
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
If YES record any adverse events as per protocol.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018759
- UMLS CUI [1,2]
- C0392747
Ähnliche Modelle
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry
C0237753 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3])
C2065135 (UMLS CUI-2)
C2065135 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0392747 (UMLS CUI [1,2])
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