ID

33026

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 form for Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry. It has to be filled in for screening (only compliance restrictions), period 1-5 and for follow-up.

Keywords

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

GlaxoSmithKline

Uploaded on

November 23, 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

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

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, Treatment Period Number, Follow up
Description

Screening, Treatment Period Number, Follow up

Data type

text

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0237753
UMLS CUI [2,2]
C1948053
UMLS CUI [3]
C1522577
Compliance Restrictions
Description

Compliance Restrictions

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C2065135
Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
Description

Requirements of compliance: -The Investigator (or designated study physician) must be informed as soon as possible about any medication taken from the time of screening until the end of the clinical phase of the study (follow-up visit). -Subjects must refrain from strenuous exercise for 48 hours before the screening visit, each treatment period and follow-up visit. -Subjects must refrain from alcohol for 24 hours prior to each treatment period until discharge from the unit (on each respective treatment period). -Subjects must refrain from grapefruit or grapefruit juice containing products from 7 days pre-dose until discharge from the unit on each dosing occasion. -Subjects must refrain from foods or beverages containing caffeine from 24 hours prior to treatment periods until discharge from the unit (on each respective treatment period). -Subjects must refrain from all recreational drugs throughout the study (screening to follow-up). Drugs of abuse tests will be performed randomly throughout the study to check this. A confirmed positive result will lead to withdrawal from the study. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.

Data type

text

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C2065135
Is the subject aware of any forthcoming requirements?
Description

Aware of forthcoming requirements

Data type

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Comments to compliance
Description

Comments

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1321605
Concomitant Medications and Adverse Event Enquiry
Description

Concomitant Medications and Adverse Event Enquiry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
Has the subject used any concomitant medications?
Description

If YES, record on CONCOMITANT MED/CATIONS page(s).

Data type

text

Alias
UMLS CUI [1]
C2347852
Has there been any change in the state of the subject's health?
Description

If YES record any adverse events as per protocol.

Data type

text

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
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Similar models

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

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
Screening, Treatment Period Number, Follow up
text
C0220908 (UMLS CUI [1])
C0237753 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3])
Period Number
Code List
Screening, Treatment Period Number, Follow up
CL Item
Screening (1)
CL Item
Treatment Period 1 (2)
CL Item
Treatment Period 2 (3)
CL Item
Treatment Period 3 (4)
CL Item
Treatment Period 4 (5)
CL Item
Follow-up (FU)
CL Item
Treatment Period 5 (6)
Item Group
Compliance Restrictions
C1321605 (UMLS CUI-1)
C2065135 (UMLS CUI-2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
text
C0525058 (UMLS CUI [1,1])
C2065135 (UMLS CUI [1,2])
Requirements compliance
Code List
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject aware of any forthcoming requirements?
text
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Aware of forthcoming requirements
Code List
Is the subject aware of any forthcoming requirements?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments to compliance
text
C0947611 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
Concomitant Medications and Adverse Event Enquiry
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Has the subject used any concomitant medications?
text
C2347852 (UMLS CUI [1])
Concomitant medications
Code List
Has the subject used any concomitant medications?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has there been any change in the state of the subject's health?
text
C0018759 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Health state, change
Code List
Has there been any change in the state of the subject's health?
CL Item
Yes (Y)
CL Item
No (N)
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