ID
41977
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 (1)
- 3/11/21 3/11/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 11, 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
Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection
Description
12-Lead ECG/ Holter/ Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
ECG - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
ECG - PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
ECG - QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
ECG - Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
ECG - QTc Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
ECG - Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
A. Rhythm
Data type
text
Alias
- UMLS CUI [1]
- C0232187
Description
Other abnormal rhythm, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Description
B. P-Wave Morphology
Data type
text
Alias
- UMLS CUI [1]
- C2216025
Description
Other morphology, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0430456
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0947611
- UMLS CUI [2,2]
- C0205394
Description
C. Conduction
Data type
text
Alias
- UMLS CUI [1]
- C0232217
Description
Other conduction, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [1,3]
- C0205394
Description
D. Myocardial Infarction
Data type
text
Alias
- UMLS CUI [1]
- C0027051
Description
Other myocardial infarction, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
E. Depolarisation/Repolarisation (QRS-T)
Data type
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
Description
Other depolarisation/repolarisation, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
- UMLS CUI [3,1]
- C0205394
- UMLS CUI [3,2]
- C0947611
Description
Other abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Description
Other abnormalities, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs - Actual date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Description
Systolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Vital Signs - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Description
Local Laboratory
Alias
- UMLS CUI-1
- C0022885
Description
Haematology - Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Description
Haematology - Has the subject fasted?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0015663
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Haematology Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Haematology - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Description
Haematology - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Description
Haematology - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Description
Clinical Chemistry Test
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Clinical Chemistry - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Clinical Chemistry - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis - Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Result of dipstick
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
If yes, provide details on the MICROSCOPY form
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Description
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Description
Dipstick Test
Data type
integer
Alias
- UMLS CUI [1]
- C0430370
Description
Dipstick - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2347373
Description
Dipstick - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2350015
Description
Dipstick - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Description
Microscopy Test
Data type
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Microscopy - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2347373
Description
Microscopy - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2350015
Description
Microscopy - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0456984
Description
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Description
Date/time of test
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C1264639
Description
FEV1 - 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
FEV1 - 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
FEV1 - 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Nasal Airflow Resistance
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0199498
Description
Date and time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Nasal Airflow Resistance - Left Nostril (150Pa)
Data type
text
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C1720438
Description
Nasal Airflow Resistance - Right Nostril (150Pa)
Data type
text
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C1720679
Description
Nasal Inspection
Alias
- UMLS CUI-1
- C0558826
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
Similar models
Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection
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C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
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C1516698 (UMLS CUI [2,2])
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C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
C0018810 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [3,1])
C0947611 (UMLS CUI [3,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
C0015663 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0008000 (UMLS CUI-2)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C2700128 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0042014 (UMLS CUI-2)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C0199498 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
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])