ID
30192
Beskrivning
Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Nasal Examination, Vital Signs, ECG and Laboratory (Visit 1).
Nyckelord
Versioner (1)
- 2018-05-18 2018-05-18 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 maj 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123
Nasal Examination, Vital Signs, ECG, Laboratory - Visit 1
- StudyEvent: ODM
Beskrivning
Nasal Examination
Alias
- UMLS CUI-1
- C0558826
Beskrivning
Patency of Left Nostril
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205091
Beskrivning
Patency of Right Nostril
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205090
Beskrivning
Septum
Datatyp
text
Alias
- UMLS CUI [1]
- C0027432
Beskrivning
Septum Deviation
Datatyp
integer
Alias
- UMLS CUI [1]
- C0549397
Beskrivning
Mucosal oedema left nostril
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205091
Beskrivning
Mucosal oedema right nostril
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205090
Beskrivning
Crusting of left nasal Mucosa
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205091
Beskrivning
Crusting of right nasal Mucosa
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205090
Beskrivning
Bleeding of Left Nasal Mucosa
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205091
Beskrivning
Bleeding of right Nasal Mucosa
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205090
Beskrivning
Secretion from left nostril
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205091
Beskrivning
Color of Secretion from left nostril
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205091
Beskrivning
Secretion from right Nostril
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205090
Beskrivning
Color of Secretion from right Nostril
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205090
Beskrivning
Ulcers on left turbinates
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205091
Beskrivning
Ulcers on left nasal septum
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205091
Beskrivning
Ulcers on right turbinates
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205090
Beskrivning
Ulcers on right nasal septum
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205090
Beskrivning
Size of the largest polyp, if present
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205091
Beskrivning
Size of the largest polyp, if present
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205091
Beskrivning
Size of the largest polyp, if present
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205090
Beskrivning
Size of the largest polyp, if present
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205090
Beskrivning
Nasal Candidiasis Examination
Alias
- UMLS CUI-1
- C2239140
- UMLS CUI-2
- C0006840
Beskrivning
Subjects with evidence of Candidiasis are not eligible for the study. f there is clinical evidence of nasal candidiasis: Ensure that a swab has been taken. Ensure that all medications used to treat the infection are recorded on the Concomitant Medications page. Ensure that nasal candidiasis when present is recorded on the Current Medical Conditions page.
Datatyp
text
Alias
- UMLS CUI [1]
- C0919658
Beskrivning
Nasal Swab taken
Datatyp
text
Alias
- UMLS CUI [1]
- C3669207
Beskrivning
Ensure that only one result of the swab has been recorded and is correct. If swab result will never be known ensure that ’Not Available’ is marked.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Date of ECG
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Beskrivning
If clinically significant abnormality, record medical condition in the (Past/current) Medical Conditions form.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Beskrivning
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
Similar models
Nasal Examination, Vital Signs, ECG, Laboratory - Visit 1
- StudyEvent: ODM
C0205091 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0028429 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0028429 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0027428 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0027428 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,2])
C1546724 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0205090 (UMLS CUI [1,2])
C1546724 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C2087484 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0027432 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C2087484 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0027432 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0006840 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])