ID
41967
Description
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis
Keywords
Versions (3)
- 2/22/21 2/22/21 -
- 2/22/21 2/22/21 -
- 2/25/21 2/25/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 25, 2021
DOI
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License
Creative Commons BY 4.0
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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356
Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product
Description
Randomisation Number (Vsit 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Description
Vital Signs - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Description
Vital Signs - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Description
Start of Challenge - Actual date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1264639
Description
Start of Challenge - Systolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0871470
Description
Start of Challenge - Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0428883
Description
Start of Challenge - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0018810
Description
Nasal Inspection (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0558826
Description
Challenge date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1264639
Description
Date/time of Assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Left Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Description
Right Nostril colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Description
Left nostril concha media turbinate Swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Left nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Left nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Description
Right nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Description
Nasal Infection
Data type
text
Alias
- UMLS CUI [1]
- C0555970
Description
Post Nasal Drip
Data type
text
Alias
- UMLS CUI [1]
- C0032781
Description
Crusting
Data type
text
Alias
- UMLS CUI [1]
- C0205204
Description
Signs of Bleeding
Data type
text
Alias
- UMLS CUI [1]
- C0019080
Description
Specify signs of bleeding
Data type
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C2348235
Description
Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0805586
- UMLS CUI-2
- C1264639
Description
Challenge (0 - 6 Hr) - Start date/time of challenge
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0805586
- UMLS CUI [2,2]
- C1301880
Description
Challenge (0 - 6 Hr) - End time of challenge
Data type
time
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C1522314
Description
Investigational Product (Dose) - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0805586
- UMLS CUI-4
- C1264639
Description
Investigational Product - Date/time of dose (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Description
Investigational Product - Treatment Confirmation (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C0750484
Description
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Description
If subject did not receive the correct treatment, record reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Similar models
Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product
C2985720 (UMLS CUI [2])
C0237753 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0805586 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1264639 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1522314 (UMLS CUI [1,2])
C0678766 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
C0678766 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0087111 (UMLS CUI-2)
C0750484 (UMLS CUI-3)
C0087111 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])