ID

41972

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

  1. 3/2/21 3/2/21 -
  2. 3/2/21 3/2/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 2, 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

Follow-Up - 12-Lead ECG; Vital Signs; Pulmonary Function Tests; Laboratory; Urinalysis

Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
12-Lead ECG/ Holter/ Telemetry ECG
Description

12-Lead ECG/ Holter/ Telemetry ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0013801
UMLS CUI-3
C1623258
UMLS CUI-4
C0039451
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
ECG - Heart rate
Description

ECG - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
ECG - PR Interval
Description

ECG - PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
ECG - QRS Duration
Description

ECG - QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
ms
ECG - Uncorrected QT Interval
Description

ECG - Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
ms
ECG - QTc Interval
Description

ECG - QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
ms
ECG - Method of QTc Calculation
Description

ECG - Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Actual date/time
Description

Vital Signs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Description

Vital Signs - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Pulmonary Function Tests
Description

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Pulmonary Function Tests - Date/time of test
Description

Pulmonary Function Tests - Date/time of test

Data type

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Description

Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Description

Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Description

Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology - Date and time sample taken
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
Haematology - Has the subject fasted?
Description

Haematology - Has the subject fasted?

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0015663
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology Test
Description

Haematology Test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Haematology - Numeric result
Description

Haematology - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
Haematology - Character result
Description

Haematology - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2350015
Haematology - No result
Description

Haematology - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clincical Chemistry - Date and time sample taken
Description

Clincical Chemistry - Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0870078
UMLS CUI [3]
C0011008
UMLS CUI [4]
C0040223
Clinical Chemistry - Has subject fasted?
Description

Clinical Chemistry - Has subject fasted?

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0015663
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-6
C0022885
UMLS CUI-7
C0008000
Clinical Chemistry Test
Description

Clinical Chemistry Test

Data type

integer

Alias
UMLS CUI [1]
C0525044
Clinical Chemistry - Numeric result
Description

Clinical Chemistry - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical Chemistry - Character result
Description

Clinical Chemistry - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Clinical Chemistry - No result
Description

Clinical Chemistry - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
Urinalysis - Local
Description

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Urinalysis - Date and time sample taken
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
Result of dipstick
Description

Result of dipstick

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Was sedimentary microscopy performed?
Description

If yes, provide details on the MICROSCOPY form

Data type

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Urinalysis - Local: Dipstick Details
Description

Urinalysis - Local: Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Dipstick Test
Description

Dipstick Test

Data type

integer

Alias
UMLS CUI [1]
C0430370
Dipstick - Numeric result
Description

Dipstick - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2347373
Dipstick - Character result
Description

Dipstick - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2350015
Dipstick - No result
Description

Dipstick - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Urinalysis - Local: Microscopy Details
Description

Urinalysis - Local: Microscopy Details

Microscopy - Date and time sample taken
Description

Microscopy - Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1]
C0430397
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0200345
UMLS CUI [3,1]
C0040223
UMLS CUI [3,2]
C0200345
Microscopy Test
Description

Microscopy Test

Data type

integer

Alias
UMLS CUI [1]
C0430397

Similar models

Follow-Up - 12-Lead ECG; Vital Signs; Pulmonary Function Tests; Laboratory; Urinalysis

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
12-Lead ECG/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
ECG - Heart rate
Item
ECG - Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
ECG - PR Interval
Item
ECG - PR Interval
integer
C0429087 (UMLS CUI [1])
ECG - QRS Duration
Item
ECG - QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
ECG - Uncorrected QT Interval
Item
ECG - Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
ECG - QTc Interval
Item
ECG - QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
ECG - Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
ECG - Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Pulmonary Function Tests - Date/time of test
Item
Pulmonary Function Tests - Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Item
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
integer
C0748133 (UMLS CUI [1])
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Item
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
integer
C0748133 (UMLS CUI [1])
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Item
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
integer
C0748133 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Haematology - Date and time sample taken
Item
Haematology - Date and time sample taken
datetime
C0018941 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
Haematology - Has the subject fasted?
Item
Haematology - Has the subject fasted?
boolean
C0018941 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Code List
Haematology Test
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Haemoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
Platelets (10)
CL Item
Reticulocyte Count (11)
CL Item
MCV (12)
CL Item
MCH (13)
CL Item
MCHC (14)
Haematology - Numeric result
Item
Haematology - Numeric result
float
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Haematology - Character result
Item
Haematology - Character result
text
C0474523 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Haematology - No result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Haematology - No result
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Clincical Chemistry - Date and time sample taken
Item
Clincical Chemistry - Date and time sample taken
datetime
C0008000 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
Clinical Chemistry - Has subject fasted?
Item
Clinical Chemistry - Has subject fasted?
boolean
C0008000 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-6)
C0008000 (UMLS CUI-7)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Code List
Clinical Chemistry Test
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilirubin (3)
CL Item
Glucose (4)
CL Item
GGT (5)
CL Item
Total Protein (6)
CL Item
Albumin (7)
CL Item
Potassium (8)
CL Item
Sodium (9)
CL Item
Chloride (10)
CL Item
Urea (11)
CL Item
Creatinine (12)
CL Item
Uric Acid (13)
CL Item
Alkaline Phosphatase (14)
CL Item
Direct Bilirubin (15)
CL Item
Calcium (16)
Clinical Chemistry - Numeric result
Item
Clinical Chemistry - Numeric result
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical Chemistry - Character result
Item
Clinical Chemistry - Character result
text
C0008000 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Clinical Chemistry - No result
integer
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Code List
Clinical Chemistry - No result
CL Item
No result (1)
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Urinalysis - Date and time sample taken
Item
Urinalysis - Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of dipstick
CL Item
No result (NR)
CL Item
Negative (NEG)
CL Item
Positive (POS)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Item
Dipstick Test
integer
C0430370 (UMLS CUI [1])
Code List
Dipstick Test
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Ketones (3)
CL Item
Bilirubin (4)
CL Item
Blood (5)
CL Item
Urobilinogen (6)
CL Item
Leucocytes (7)
CL Item
Specific Gravity (8)
Dipstick - Numeric result
Item
Dipstick - Numeric result
float
C0430370 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Dipstick - Character result
Item
Dipstick - Character result
text
C0430370 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Dipstick - No result
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Dipstick - No result
CL Item
No result (1)
Item Group
Urinalysis - Local: Microscopy Details
Microscopy - Date and time sample taken
Item
Microscopy - Date and time sample taken
datetime
C0430397 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
Item
Microscopy Test
integer
C0430397 (UMLS CUI [1])
Code List
Microscopy Test
CL Item
White blood cells (1)
CL Item
Red blood cells (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)

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