ID

33704

Beschreibung

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains logs and repeat. It has to be filled in for the end of study.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Stichworte

Versionen (3)
  1. 20.12.18 20.12.18 -
  2. 20.12.18 20.12.18 -
  3. 27.09.21 27.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Dezember 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Englisch

Logs and repeat

1 Formulare  
  1. StudyEvent: ODM
    1. Logs and repeat
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Adverse event/Concomitant medication/unscheduled assessment check questions
Beschreibung

Adverse event/Concomitant medication/unscheduled assessment check questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
Were any concomitant medications taken by the subject during the study?
Beschreibung

Take of concomitant medication

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Beschreibung

Non-serious adverse events

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Did the subject experience any investigational Product Device Malfunctions?
Beschreibung

Investigational Product Device Malfunctions

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0086138
Did the subject experience any serious adverse events during the study?
Beschreibung

Serious adverse events

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Were any unscheduled haematology or clinical chemistry samples taken?
Beschreibung

Take of unscheduled haematology or clinical chemistry samples

Datentyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0008000
UMLS CUI [2,1]
C3854240
UMLS CUI [2,2]
C0018941
Were any unscheduled urinalysis samples taken?
Beschreibung

Take of unscheduled urinalysis samples

Datentyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0042014
Were any unscheduled ECGs performed?
Beschreibung

Unscheduled ECGs

Datentyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0013798
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Beschreibung

Abnormal, clinically significant ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2985739
Were any unscheduled vital signs recorded?
Beschreibung

Unscheduled vital signs

Datentyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0518766
Were any chest x-rays taken for suspected Pneumonia?
Beschreibung

Take of chest x-rays

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0032285
UMLS CUI [1,3]
C0750491
Were any unscheduled FEV1 performed?
Beschreibung

Unscheduled FEV1

Datentyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0748133
Were any unscheduled PK blood samples taken?
Beschreibung

Take of unscheduled PK blood

Datentyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0031328
UMLS CUI [2,1]
C3854240
UMLS CUI [2,2]
C0178913
Liver event
Beschreibung

Liver event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
Beschreibung

lf Yes to Liver events, go to the LE DETAILS visit and complete the Liver event forms

Datentyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
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Ähnliche Modelle

Logs and repeat

1 Formulare
  1. StudyEvent: ODM
    1. Logs and repeat
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Adverse event/Concomitant medication/unscheduled assessment check questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Take of concomitant medication
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Take of concomitant medication
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any investigational Product Device Malfunctions?
text
C0304229 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
Take of concomitant medication
Code List
Did the subject experience any investigational Product Device Malfunctions?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Take of concomitant medication
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled haematology or clinical chemistry samples taken?
text
C3854240 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
Take of concomitant medication
Code List
Were any unscheduled haematology or clinical chemistry samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled urinalysis samples taken?
text
C3854240 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Take of unscheduled urinalysis samples
Code List
Were any unscheduled urinalysis samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled ECGs performed?
text
C3854240 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Take of unscheduled urinalysis samples
Code List
Were any unscheduled ECGs performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
text
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Take of unscheduled urinalysis samples
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled vital signs recorded?
text
C3854240 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Take of unscheduled urinalysis samples
Code List
Were any unscheduled vital signs recorded?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any chest x-rays taken for suspected Pneumonia?
text
C0039985 (UMLS CUI [1,1])
C0032285 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
Take of unscheduled urinalysis samples
Code List
Were any chest x-rays taken for suspected Pneumonia?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled FEV1 performed?
text
C3854240 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Take of unscheduled urinalysis samples
Code List
Were any unscheduled FEV1 performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled PK blood samples taken?
text
C3854240 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Take of unscheduled urinalysis samples
Code List
Were any unscheduled PK blood samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Liver event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Liver events reaching stopping criteria
Code List
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)
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