ID

30188

Description

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 Administrative Data; Visit 2, Week 0, Day 1.

Keywords

Versions (1)
  1. 5/18/18 5/18/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 18, 2018

DOI

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License

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

English

Administrative Data - Visit 2

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Randomisation Criteria
Description

Randomisation Criteria

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0243161
Did the subject meet all the randomisation criteria?
Description

If no, answer the following items of this itemgroup.

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0243161
Reflective total nasal symptom scores (rTNSS) must be ≥ 4 during 4 of the last 7 days prior to Visit 2. This includes the assessment completed on the morning of the randomisation visit.
Description

Reflective total nasal symptom scores

Data type

boolean

Alias
UMLS CUI [1,1]
C3533163
UMLS CUI [1,2]
C0028429
Must have completed 80percent of assessments on the screening symptom diary cards
Description

Screening symptom diary cards

Data type

boolean

Alias
UMLS CUI [1,1]
C2216446
UMLS CUI [1,2]
C3176968
Must have completed a 24-hour urine cortisol collection (minimum urine volumes must be 600mL for females and 800mL for males).
Description

24-hour urine cortisol collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0455060
UMLS CUI [1,2]
C0201968
Must have completed slit lamp and funduscopic examinations, including evaluation of cataract formation performed by a licensed ophthalmologist or optometrist and results are within normal limits.
Description

Slit Lamp, Fundoscopic Examination within normal limits

Data type

boolean

Alias
UMLS CUI [1]
C0029090
UMLS CUI [2]
C0419360
Must have completed an evaluation for glaucoma and intraocular pressure performed by a licensed ophthalmologist or optometrist and results are within normal limits.
Description

Glaucoma, intraocular pressure within normal limits

Data type

boolean

Alias
UMLS CUI [1]
C0578862
UMLS CUI [2]
C0017601
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
If all randomisation criteria are met, write down assigned randomization number.
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational Product Container Number
Description

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational Product Container Number
Description

Investigational Product Container Number

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
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Similar models

Administrative Data - Visit 2

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Randomisation Criteria
C0034656 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Item
Did the subject meet all the randomisation criteria?
text
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Randomization criteria
Code List
Did the subject meet all the randomisation criteria?
CL Item
Yes (Y)
CL Item
No (N)
Reflective total nasal symptom scores
Item
Reflective total nasal symptom scores (rTNSS) must be ≥ 4 during 4 of the last 7 days prior to Visit 2. This includes the assessment completed on the morning of the randomisation visit.
boolean
C3533163 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
Screening symptom diary cards
Item
Must have completed 80percent of assessments on the screening symptom diary cards
boolean
C2216446 (UMLS CUI [1,1])
C3176968 (UMLS CUI [1,2])
24-hour urine cortisol collection
Item
Must have completed a 24-hour urine cortisol collection (minimum urine volumes must be 600mL for females and 800mL for males).
boolean
C0455060 (UMLS CUI [1,1])
C0201968 (UMLS CUI [1,2])
Slit Lamp, Fundoscopic Examination within normal limits
Item
Must have completed slit lamp and funduscopic examinations, including evaluation of cataract formation performed by a licensed ophthalmologist or optometrist and results are within normal limits.
boolean
C0029090 (UMLS CUI [1])
C0419360 (UMLS CUI [2])
Glaucoma, intraocular pressure within normal limits
Item
Must have completed an evaluation for glaucoma and intraocular pressure performed by a licensed ophthalmologist or optometrist and results are within normal limits.
boolean
C0578862 (UMLS CUI [1])
C0017601 (UMLS CUI [2])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
If all randomisation criteria are met, write down assigned randomization number.
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational Product Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational Product Container Number
Item
Investigational Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
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