ID

32968

Description

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma 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 propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the lung function form. It has to be filled in at screening, sessions 2, 3, 4, 5 and 6.

Keywords

Versions (3)
  1. 11/14/18 11/14/18 -
  2. 11/22/18 11/22/18 -
  3. 11/23/18 11/23/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

English

Lung function

1 forms  
  1. StudyEvent: ODM
    1. Lung function
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Session Number
Description

Session Number

Data type

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Lung Function Tests
Description

Lung Function Tests

Alias
UMLS CUI-1
C0024119
Test number
Description

Test number

Data type

integer

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0237753
Date of Lung function
Description

Date of Lung function

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
Planned relative time
Description

time relative to dosing

Data type

text

Alias
UMLS CUI [1]
C0439564
Actual time of first reading
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Reading Number
Description

Three readings are expected for each test.

Data type

integer

Alias
UMLS CUI [1,1]
C1522609
UMLS CUI [1,2]
C0456984
Test result of readings
Description

Test result of readings

Data type

float

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Highest reading
Description

Only for screening session

Data type

float

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0024119
Predicted normal
Description

Only for screening session

Data type

float

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0024119
% Predicted normal
Description

Only for screening session. Quotient of: (Highest reading) / (Predicted normal) x100

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0024119
%
Is the subject’s FEV1 and PEF >80% of predicted?
Description

Only for screening session. If NO, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0521299
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Similar models

Lung function

1 forms
  1. StudyEvent: ODM
    1. Lung function
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
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item Group
Lung Function Tests
C0024119 (UMLS CUI-1)
Item
Test number
integer
C0039593 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Row no.
Code List
Test number
CL Item
FEV1 (L) (1)
CL Item
PEF (L/min) (2)
Date of Lung function
Item
Date of Lung function
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Screening (S)
CL Item
Unscheduled (U)
CL Item
Pre dose (P)
Actual time of first reading
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1])
Item
Reading Number
integer
C1522609 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading Number
Code List
Reading Number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Test result of readings
Item
Test result of readings
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Highest reading
Item
Highest reading
float
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
Predicted normal
Item
Predicted normal
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
% Predicted normal
Item
% Predicted normal
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
Item
Is the subject’s FEV1 and PEF >80% of predicted?
text
C0748133 (UMLS CUI [1])
C0521299 (UMLS CUI [2])
FEV1, PEF
Code List
Is the subject’s FEV1 and PEF >80% of predicted?
CL Item
Yes (Y)
CL Item
No (N)
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