ID

33694

Description

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 the Holter ECG . It has to be filled in for screening and treatment periods 1-4. For Screening and Day 7: 0-24 Hour Holter results. For Day-1: 0-12 Hour Holter results. For Day 1: 0-2 Hour Holter results.

Link

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

Keywords

Versions (2)
  1. 12/20/18 12/20/18 -
  2. 12/20/18 12/20/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 20, 2018

DOI

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License

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

English

Holter ECG

1 forms  
  1. StudyEvent: ODM
    1. Holter ECG
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 visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

For Screening and Day 7: 0-24 Hour Holter results. For Day-1: 0-12 Hour Holter results. For Day 1: 0-2 Hour Holter results.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Holter ECG (Holter)
Description

Holter ECG (Holter)

Alias
UMLS CUI-1
C0013801
Start date of Holter
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start time of Holter
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop date of Holter
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop time of Holter
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Interpretation of Holter
Description

only for screening. 4 + 5: optional items

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
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Similar models

Holter ECG

1 forms
  1. StudyEvent: ODM
    1. Holter ECG
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 visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
screening (1)
CL Item
TP1D-1 (2)
CL Item
TP1D1 (3)
CL Item
TP1D7 (4)
CL Item
TP2D1 (5)
CL Item
TP2D7 (6)
CL Item
TP3D1 (7)
CL Item
TP3D7 (8)
CL Item
TP4D1 (9)
CL Item
TP4D1 (10)
Item Group
Holter ECG (Holter)
C0013801 (UMLS CUI-1)
Start date of Holter
Item
Start date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of Holter
Item
Start time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop date of Holter
Item
Stop date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop time of Holter
Item
Stop time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Interpretation or Holter
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (4)
CL Item
unable to evaluate (5)
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