ID

34975

Beskrivning

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. 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 furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains Pulmonary function test form. It has to be filled in for screening, treatment periods 1-4 for Day 1 and in follow-up.

Nyckelord

Versioner (2)
  1. 2019-02-04 2019-02-04 -
  2. 2019-02-06 2019-02-06 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 februari 2019

DOI

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Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Engelsk

Pulmonary function test

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Pulmonary function tests
Beskrivning

Pulmonary function tests

Alias
UMLS CUI-1
C0024119
Date of testing
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
Type of Test
Beskrivning

Type of Test

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0024119
Units
Beskrivning

For FEV1 and FVC: L For PEFR: L/min

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Planned relative time
Beskrivning

For each timepoint and each test take three readings. - Pre-dose, 1h, 12h and 24 h only for treatment periods (TP1-4D1).

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary function time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
Reading Number 1, test result
Beskrivning

Ensure that FEV1 has been rounded accurately to 2 decimal places.

Datatyp

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0456984
Reading Number 2, test result
Beskrivning

Ensure that FEV1 has been rounded accurately to 2 decimal places.

Datatyp

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0456984
Reading Number 3, test result
Beskrivning

Ensure that FEV1 has been rounded accurately to 2 decimal places.

Datatyp

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0456984
Investigator Calculation FEV1
Beskrivning

Investigator Calculation FEV1

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1441506
UMLS CUI-3
C0429706
Planned relative time
Beskrivning

Planned relative time

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Highest reading result
Beskrivning

Only for screening

Datatyp

float

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0429706
Predicted normal reading result
Beskrivning

Only for screening

Datatyp

float

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0429706
% Predicted normal reading result
Beskrivning

Only for screening. % Predicted normal test result = (Highest test result/predicted normal test result) x 100 Note: Ensure that % Predicted Normal(s) calculation(s) is/are correct and within the protocol specified range(s). Ensure that% Predicted Normal has been rounded accurately to 1 decimal place.

Datatyp

float

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0429706
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Similar models

Pulmonary function test

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (1)
CL Item
TP1D1 (2)
CL Item
TP2D1 (3)
CL Item
TP3D1 (4)
CL Item
TP4D1 (5)
CL Item
Follow-up (6)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Pulmonary function tests
C0024119 (UMLS CUI-1)
Date of testing
Item
Date of testing
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Item
Type of Test
integer
C0332307 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Type of Test
Code List
Type of Test
CL Item
FEV1 (1)
CL Item
FVC (2)
CL Item
PEFR (3)
Item
Units
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
L (1)
CL Item
L/min (2)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Screening (1)
CL Item
Pre-dose (2)
CL Item
1 h (3)
CL Item
12 h (4)
CL Item
24 h (5)
CL Item
Follow-up (6)
CL Item
unscheduled (7)
Pulmonary function time
Item
Pulmonary function time
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading Number 1, test result
Item
Reading Number 1, test result
float
C0024119 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading Number 2, test result
Item
Reading Number 2, test result
float
C0024119 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading Number 3, test result
Item
Reading Number 3, test result
float
C0024119 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
Investigator Calculation FEV1
C0008961 (UMLS CUI-1)
C1441506 (UMLS CUI-2)
C0429706 (UMLS CUI-3)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Screening scheduled (1)
CL Item
Unscheduled (2)
Highest reading result
Item
Highest reading result
float
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,3])
Predicted normal reading result
Item
Predicted normal reading result
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,3])
% Predicted normal reading result
Item
% Predicted normal reading result
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,3])
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