ID

32719

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 Physical examination, medical history and state of training of subject. It has to be filled in at screening.

Mots-clés

Versions (3)
  1. 13/11/2018 13/11/2018 -
  2. 16/11/2018 16/11/2018 -
  3. 22/11/2018 22/11/2018 -
Détendeur de droits

GlaxoSmithKline

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13 novembre 2018

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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

Anglais

Medical history, training and physical examination

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Description

Date of screening

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Medical History
Description

Medical History

Alias
UMLS CUI-1
C0262926
Ear, Nose and Throat
Description

Ear, Nose and Throat

Type de données

text

Alias
UMLS CUI [1,1]
C0013443
UMLS CUI [1,2]
C0028429
UMLS CUI [1,3]
C0031354
Eyes
Description

Eyes

Type de données

text

Alias
UMLS CUI [1]
C0015392
Respiratory
Description

Respiratory

Type de données

text

Alias
UMLS CUI [1]
C0035237
Cardiovascular
Description

Cardiovascular

Type de données

text

Alias
UMLS CUI [1]
C0007226
Gastrointestinal
Description

Gastrointestinal

Type de données

text

Alias
UMLS CUI [1]
C0017189
Hepatobiliary and pancreas
Description

Hepatobiliary and pancreas

Type de données

text

Alias
UMLS CUI [1,1]
C1711359
UMLS CUI [1,2]
C0030274
Urology
Description

Urology

Type de données

text

Alias
UMLS CUI [1]
C0042077
Reproduction
Description

Reproduction

Type de données

text

Alias
UMLS CUI [1]
C0035150
Neurology
Description

Neurology

Type de données

text

Alias
UMLS CUI [1]
C0027763
Blood and lymphatic
Description

Blood and lymphatic

Type de données

text

Alias
UMLS CUI [1,1]
C0279810
UMLS CUI [1,2]
C0024235
Endocrine and metabolic
Description

Endocrine and metabolic

Type de données

text

Alias
UMLS CUI [1]
C3841737
Musculoskeletal
Description

Musculoskeletal

Type de données

text

Alias
UMLS CUI [1]
C0026860
Skin
Description

Skin

Type de données

text

Alias
UMLS CUI [1]
C1123023
Psychiatry
Description

Psychiatry

Type de données

text

Alias
UMLS CUI [1]
C0278060
Allergies
Description

Allergies

Type de données

text

Alias
UMLS CUI [1]
C0020517
If a box above is ticked, describe concisely for each.
Description

Description of medical history

Type de données

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0262926
Training
Description

Training

Alias
UMLS CUI-1
C0015259
Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
Description

Accuhaler, MDI, spacer training

Type de données

text

Alias
UMLS CUI [1,1]
C0939246
UMLS CUI [1,2]
C0015259
UMLS CUI [2,1]
C0993596
UMLS CUI [2,2]
C0015259
UMLS CUI [3,1]
C0592626
UMLS CUI [3,2]
C0015259
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Hair and Skin
Description

Hair and Skin

Type de données

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Lymph nodes
Description

Lymph nodes

Type de données

text

Alias
UMLS CUI [1]
C0024204
Eyes
Description

Eyes

Type de données

text

Alias
UMLS CUI [1]
C0015392
Ear, Nose and Throat
Description

Ear, Nose and Throat

Type de données

text

Alias
UMLS CUI [1,1]
C0013443
UMLS CUI [1,2]
C0028429
UMLS CUI [1,3]
C0031354
Breasts
Description

Breasts

Type de données

text

Alias
UMLS CUI [1]
C0199850
Respiratory
Description

Respiratory

Type de données

text

Alias
UMLS CUI [1]
C0035237
Cardiovascular
Description

Cardiovascular

Type de données

text

Alias
UMLS CUI [1]
C0007226
Abdomen
Description

Abdomen

Type de données

text

Alias
UMLS CUI [1]
C0000726
Urogenital
Description

Urogenital

Type de données

text

Alias
UMLS CUI [1]
C1828035
Pelvic
Description

Pelvic

Type de données

text

Alias
UMLS CUI [1]
C0030797
Rectal
Description

Rectal

Type de données

text

Alias
UMLS CUI [1]
C0199900
Musculoskeletal
Description

Musculoskeletal

Type de données

text

Alias
UMLS CUI [1]
C0026860
Neurological
Description

Neurological

Type de données

text

Alias
UMLS CUI [1]
C0027853
Mental Status
Description

Mental Status

Type de données

text

Alias
UMLS CUI [1]
C0278060
If a box above is ticked, describe concisely for each.
Description

Description of physical examination

Type de données

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0031809
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Similar models

Medical history, training and physical examination

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of screening
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Medical History
C0262926 (UMLS CUI-1)
Item
Ear, Nose and Throat
text
C0013443 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
C0031354 (UMLS CUI [1,3])
Ear, Nose and Throat
Code List
Ear, Nose and Throat
CL Item
No (N)
CL Item
Yes (Y)
Item
Eyes
text
C0015392 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Eyes
CL Item
No (N)
CL Item
Yes (Y)
Item
Respiratory
text
C0035237 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Respiratory
CL Item
No (N)
CL Item
Yes (Y)
Item
Cardiovascular
text
C0007226 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Cardiovascular
CL Item
No (N)
CL Item
Yes (Y)
Item
Gastrointestinal
text
C0017189 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Gastrointestinal
CL Item
No (N)
CL Item
Yes (Y)
Item
Hepatobiliary and pancreas
text
C1711359 (UMLS CUI [1,1])
C0030274 (UMLS CUI [1,2])
Hepatobiliary and pancreas
Code List
Hepatobiliary and pancreas
CL Item
No (N)
CL Item
Yes (Y)
Item
Urology
text
C0042077 (UMLS CUI [1])
Urology
Code List
Urology
CL Item
No (N)
CL Item
Yes (Y)
Item
Reproduction
text
C0035150 (UMLS CUI [1])
Urology
Code List
Reproduction
CL Item
No (N)
CL Item
Yes (Y)
Item
Neurology
text
C0027763 (UMLS CUI [1])
Urology
Code List
Neurology
CL Item
No (N)
CL Item
Yes (Y)
Item
Blood and lymphatic
text
C0279810 (UMLS CUI [1,1])
C0024235 (UMLS CUI [1,2])
Urology
Code List
Blood and lymphatic
CL Item
No (N)
CL Item
Yes (Y)
Item
Endocrine and metabolic
text
C3841737 (UMLS CUI [1])
Urology
Code List
Endocrine and metabolic
CL Item
No (N)
CL Item
Yes (Y)
Item
Musculoskeletal
text
C0026860 (UMLS CUI [1])
Urology
Code List
Musculoskeletal
CL Item
No (N)
CL Item
Yes (Y)
Item
Skin
text
C1123023 (UMLS CUI [1])
Urology
Code List
Skin
CL Item
No (N)
CL Item
Yes (Y)
Item
Psychiatry
text
C0278060 (UMLS CUI [1])
Urology
Code List
Psychiatry
CL Item
No (N)
CL Item
Yes (Y)
Item
Allergies
text
C0020517 (UMLS CUI [1])
Urology
Code List
Allergies
CL Item
No (N)
CL Item
Yes (Y)
Description of medical history
Item
If a box above is ticked, describe concisely for each.
text
C0678257 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Item Group
Training
C0015259 (UMLS CUI-1)
Item
Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
text
C0939246 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0993596 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0592626 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
Accuhaler, MDI, spacer training
Code List
Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Hair and Skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Ear, Nose and Throat
Code List
Hair and Skin
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Lymph nodes
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Eyes
text
C0015392 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Eyes
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Ear, Nose and Throat
text
C0013443 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
C0031354 (UMLS CUI [1,3])
Ear, Nose and Throat
Code List
Ear, Nose and Throat
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Breasts
text
C0199850 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Breasts
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Item
Respiratory
text
C0035237 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Respiratory
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Cardiovascular
text
C0007226 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Cardiovascular
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Abdomen
text
C0000726 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Abdomen
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Urogenital
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Item
Pelvic
text
C0030797 (UMLS CUI [1])
Ear, Nose and Throat
Code List
Pelvic
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Item
Rectal
text
C0199900 (UMLS CUI [1])
Urology
Code List
Rectal
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Item
Musculoskeletal
text
C0026860 (UMLS CUI [1])
Urology
Code List
Musculoskeletal
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Neurological
text
C0027853 (UMLS CUI [1])
Urology
Code List
Neurological
CL Item
Normal (N)
CL Item
Abnormal (AN)
Item
Mental Status
text
C0278060 (UMLS CUI [1])
Urology
Code List
Mental Status
CL Item
Normal (N)
CL Item
Abnormal (AN)
Description of physical examination
Item
If a box above is ticked, describe concisely for each.
text
C0678257 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
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