ID

32719

Descripción

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.

Palabras clave

Versiones (3)
  1. 13/11/18 13/11/18 -
  2. 16/11/18 16/11/18 -
  3. 22/11/18 22/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 de noviembre de 2018

DOI

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Licencia

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

Inglés

Medical history, training and physical examination

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Descripción

Date of screening

Tipo de datos

date

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

Medical History

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

Ear, Nose and Throat

Tipo de datos

text

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

Eyes

Tipo de datos

text

Alias
UMLS CUI [1]
C0015392
Respiratory
Descripción

Respiratory

Tipo de datos

text

Alias
UMLS CUI [1]
C0035237
Cardiovascular
Descripción

Cardiovascular

Tipo de datos

text

Alias
UMLS CUI [1]
C0007226
Gastrointestinal
Descripción

Gastrointestinal

Tipo de datos

text

Alias
UMLS CUI [1]
C0017189
Hepatobiliary and pancreas
Descripción

Hepatobiliary and pancreas

Tipo de datos

text

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

Urology

Tipo de datos

text

Alias
UMLS CUI [1]
C0042077
Reproduction
Descripción

Reproduction

Tipo de datos

text

Alias
UMLS CUI [1]
C0035150
Neurology
Descripción

Neurology

Tipo de datos

text

Alias
UMLS CUI [1]
C0027763
Blood and lymphatic
Descripción

Blood and lymphatic

Tipo de datos

text

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

Endocrine and metabolic

Tipo de datos

text

Alias
UMLS CUI [1]
C3841737
Musculoskeletal
Descripción

Musculoskeletal

Tipo de datos

text

Alias
UMLS CUI [1]
C0026860
Skin
Descripción

Skin

Tipo de datos

text

Alias
UMLS CUI [1]
C1123023
Psychiatry
Descripción

Psychiatry

Tipo de datos

text

Alias
UMLS CUI [1]
C0278060
Allergies
Descripción

Allergies

Tipo de datos

text

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

Description of medical history

Tipo de datos

text

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

Training

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

Accuhaler, MDI, spacer training

Tipo de datos

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
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Hair and Skin
Descripción

Hair and Skin

Tipo de datos

text

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

Lymph nodes

Tipo de datos

text

Alias
UMLS CUI [1]
C0024204
Eyes
Descripción

Eyes

Tipo de datos

text

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

Ear, Nose and Throat

Tipo de datos

text

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

Breasts

Tipo de datos

text

Alias
UMLS CUI [1]
C0199850
Respiratory
Descripción

Respiratory

Tipo de datos

text

Alias
UMLS CUI [1]
C0035237
Cardiovascular
Descripción

Cardiovascular

Tipo de datos

text

Alias
UMLS CUI [1]
C0007226
Abdomen
Descripción

Abdomen

Tipo de datos

text

Alias
UMLS CUI [1]
C0000726
Urogenital
Descripción

Urogenital

Tipo de datos

text

Alias
UMLS CUI [1]
C1828035
Pelvic
Descripción

Pelvic

Tipo de datos

text

Alias
UMLS CUI [1]
C0030797
Rectal
Descripción

Rectal

Tipo de datos

text

Alias
UMLS CUI [1]
C0199900
Musculoskeletal
Descripción

Musculoskeletal

Tipo de datos

text

Alias
UMLS CUI [1]
C0026860
Neurological
Descripción

Neurological

Tipo de datos

text

Alias
UMLS CUI [1]
C0027853
Mental Status
Descripción

Mental Status

Tipo de datos

text

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

Description of physical examination

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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