ID

34117

Description

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive. This form contains information about lung function tests during screening procedure. It has to be filled in in Session 1.

Keywords

Versions (1)
  1. 1/14/19 1/14/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

English

Lung function tests: Screening

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
Screening
Description

Screening

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0220908
Row number
Description

Row number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
Test
Description

Lung function test. Each test should be performed during screening procedure.

Data type

text

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0024119
UMLS CUI [2,2]
C1287681
UMLS CUI [3,1]
C0024119
UMLS CUI [3,2]
C0429745
Actual time of first reading
Description

Actual time of first reading

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C0024119
Reading 1
Description

Reading 1

Data type

float

Alias
UMLS CUI [1]
C0242485
Reading 2
Description

Reading 2

Data type

float

Alias
UMLS CUI [1]
C0242485
Reading 3
Description

Reading 3

Data type

float

Alias
UMLS CUI [1]
C0242485
Highest reading
Description

According to form, highest reading should only be filled in for FEV1 and FVC. In this study, highest reading should not be entered anywhere.

Data type

float

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0748133
UMLS CUI [2,1]
C1522410
UMLS CUI [2,2]
C0456984
UMLS CUI [2,3]
C1287681
Predicted normal
Description

Predicted normal should only be filled in for FEV1.

Data type

float

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0205307
Percent predicted normal
Description

According to form, Percent predicted normal should only be filled in for FEV1. To obtain this value, divide 'Highest reading' by 'Predicted normal' and multiply with 100. In this study, Percent predicted normal should not be entered anywhere.

Data type

float

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0439165
FEV1/FVC ratio
Description

In this study, FEV1/FVC ratio should not be entered.

Data type

float

Alias
UMLS CUI [1,1]
C0429745
UMLS CUI [1,2]
C0456603
Is the FEV1 >80 percent of predicted and the FEV1/FVC ratio >0.7?
Description

According to form: If NO, EXCLUDE subject from the study. In this study, this question should not bei answered.

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C0429745
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Similar models

Lung function tests: Screening

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])
Item Group
Screening
C0024119 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Item
Test
text
C0748133 (UMLS CUI [1])
C0024119 (UMLS CUI [2,1])
C1287681 (UMLS CUI [2,2])
C0024119 (UMLS CUI [3,1])
C0429745 (UMLS CUI [3,2])
Test
Code List
Test
CL Item
FEV1 (FEV1)
CL Item
FVC (FVC)
CL Item
FEV1/FVC (FEV1/FVC)
Actual time of first reading
Item
Actual time of first reading
time
C1301880 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
Reading 1
Item
Reading 1
float
C0242485 (UMLS CUI [1])
Reading 2
Item
Reading 2
float
C0242485 (UMLS CUI [1])
Reading 3
Item
Reading 3
float
C0242485 (UMLS CUI [1])
Highest reading
Item
Highest reading
float
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
C1522410 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C1287681 (UMLS CUI [2,3])
Predicted normal
Item
Predicted normal
float
C0748133 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Percent predicted normal
Item
Percent predicted normal
float
C0748133 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
FEV1/FVC ratio
Item
FEV1/FVC ratio
float
C0429745 (UMLS CUI [1,1])
C0456603 (UMLS CUI [1,2])
Is the FEV1 >80 percent of predicted and the FEV1/FVC ratio >0.7?
Item
Is the FEV1 >80 percent of predicted and the FEV1/FVC ratio >0.7?
boolean
C0748133 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0429745 (UMLS CUI [2])
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