ID

33699

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 Demography of subject and subject data. It has to be filled in for screening.

Link

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

Keywords

Versions (2)
  1. 19-12-18 19-12-18 -
  2. 20-12-18 20-12-18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

20 december 2018

DOI

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License

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

English

Demography, subject data

1 forms  
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
Subject data
Description

Subject data

Alias
UMLS CUI-1
C1997894
UMLS CUI-2
C2986440
Subject initials
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
If female, record child-bearing potential
Description

Child-bearing potential

Data type

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Alias
UMLS CUI-1
C0015031
Ethnic group
Description

Ethnic group

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Geographic Ancestry

Alias
UMLS CUI-1
C0034510
African American/African Heritage
Description

African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
Amerlcan Indian or Alaskan Native
Description

American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - central/South Asian Heritage
Description

Asian - central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

Asian - Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

Asian - South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

White - Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C0026068
White - White/Caucasian/European Heritage
Description

White - White/Caucasian/European Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demography, subject data

1 forms
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 Group
Subject data
C1997894 (UMLS CUI-1)
C2986440 (UMLS CUI-2)
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
If female, record child-bearing potential
integer
C3831118 (UMLS CUI [1])
Child-bearing potential
Code List
If female, record child-bearing potential
CL Item
Post-menopausal (1)
CL Item
Sterile (of chlld-bearing age) (2)
CL Item
Potentially able to bear children (3)
Item Group
Ethnicity
C0015031 (UMLS CUI-1)
Item
Ethnic group
integer
C0015031 (UMLS CUI [1])
Ethnicity group
Code List
Ethnic group
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic Ancestry
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
Amerlcan Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - central/South Asian Heritage
Item
Asian - central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C0026068 (UMLS CUI [2])
White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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