ID

34002

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, 4 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 pulmonary function test. It has to be filled in for screening and for repeat if required. Take three measurements for each subject.

Link

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

Keywords

  1. 1/6/19 1/6/19 -
  2. 1/8/19 1/8/19 -
  3. 1/10/19 1/10/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2019

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

Pulmonary function test for screening and repeat

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of test
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826247
Time of test
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0429928
Pulmonary function tests (PFT)
Description

Pulmonary function tests (PFT)

Alias
UMLS CUI-1
C0024119
FEV1 test
Description

Take three readings for each subject. Note the results in following item.

Data type

integer

Alias
UMLS CUI [1]
C0748133
FEV1 result
Description

FEV1 result

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C1274040
L

Similar models

Pulmonary function test for screening and repeat

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])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Screening (1)
CL Item
Repeat (2)
Date of test
Item
Date of test
date
C2826247 (UMLS CUI [1])
Time of test
Item
Time of test
time
C0429928 (UMLS CUI [1])
Item Group
Pulmonary function tests (PFT)
C0024119 (UMLS CUI-1)
Item
FEV1 test
integer
C0748133 (UMLS CUI [1])
Code List
FEV1 test
CL Item
Reading 1 (1)
CL Item
Reading 2 (2)
CL Item
Reading 3 (3)
FEV1 result
Item
FEV1 result
float
C0748133 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

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