ID

34918

Beschrijving

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.

Trefwoorden

Versies (2)
  1. 04-02-19 04-02-19 -
  2. 06-02-19 06-02-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 februari 2019

DOI

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Licentie

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

Engels

Pulmonary function test

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Beschrijving

Visit Type

Datatype

integer

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

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Pulmonary function tests
Beschrijving

Pulmonary function tests

Alias
UMLS CUI-1
C0024119
Date of testing
Beschrijving

day month year

Datatype

date

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

Type of Test

Datatype

integer

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

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

Datatype

integer

Alias
UMLS CUI [1]
C1519795
Planned relative time
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary function time
Beschrijving

00:00-23:59

Datatype

time

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

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

Datatype

float

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

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

Datatype

float

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

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

Datatype

float

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

Investigator Calculation

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0024119
UMLS CUI-3
C1441506
Planned relative time
Beschrijving

Planned relative time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Highest reading result
Beschrijving

Only for screening

Datatype

float

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

Only for screening

Datatype

float

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

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.

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
C0008961 (UMLS CUI-1)
C0024119 (UMLS CUI-2)
C1441506 (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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