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)
  1. 2/22/21 2/22/21 -
  2. 2/22/21 2/22/21 -
  3. 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

English

Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product

1 forms  
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]
C1320303
UMLS CUI [2]
C2985720
Randomisation Number (Vsit 1)
Description

Randomisation Number (Vsit 1)

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Was the subject able to be randomised?

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Provide Randomisation number
Description

Provide Randomisation number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Vital Signs - Challenge Date and Time (Visit 1, 3, 5)
Description

Vital Signs - Challenge Date and Time (Visit 1, 3, 5)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0805586
UMLS CUI-3
C1264639
Vital Signs - Challenge date/time
Description

Vital Signs - Challenge date/time

Data type

datetime

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0805586
UMLS CUI [2,2]
C1264639
Vital Signs - Start of Challenge (Visit 1, 3, 5)
Description

Vital Signs - Start of Challenge (Visit 1, 3, 5)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0805586
UMLS CUI-3
C0808070
Start of Challenge - Actual date/time
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
Start of Challenge - Systolic Blood Pressure
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
mm[Hg]
Start of Challenge - Diastolic Blood Pressure
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
mm[Hg]
Start of Challenge - Heart rate
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
beats/min
Nasal Inspection (Visit 1, 3, 5)
Description

Nasal Inspection (Visit 1, 3, 5)

Alias
UMLS CUI-1
C0558826
Challenge date/time
Description

Challenge date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1264639
Date/time of Assessment
Description

Date/time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Left Nostril Colour
Description

Left Nostril Colour

Data type

text

Alias
UMLS CUI [1,1]
C0475705
UMLS CUI [1,2]
C1720438
Right Nostril colour
Description

Right Nostril colour

Data type

text

Alias
UMLS CUI [1,1]
C0475705
UMLS CUI [1,2]
C1720679
Left nostril concha media turbinate Swelling
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
Left nostril concha inferior turbinate swelling
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
Right nostril concha media turbinate swelling
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
Right nostril concha inferior turbinate swelling
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
Left nostril secretions
Description

Left nostril secretions

Data type

text

Alias
UMLS CUI [1,1]
C1720438
UMLS CUI [1,2]
C0036537
Right nostril secretions
Description

Right nostril secretions

Data type

text

Alias
UMLS CUI [1,1]
C1720679
UMLS CUI [1,2]
C0036537
Nasal Infection
Description

Nasal Infection

Data type

text

Alias
UMLS CUI [1]
C0555970
Post Nasal Drip
Description

Post Nasal Drip

Data type

text

Alias
UMLS CUI [1]
C0032781
Crusting
Description

Crusting

Data type

text

Alias
UMLS CUI [1]
C0205204
Signs of Bleeding
Description

Signs of Bleeding

Data type

text

Alias
UMLS CUI [1]
C0019080
Specify signs of bleeding
Description

Specify signs of bleeding

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C2348235
Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)
Description

Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)

Alias
UMLS CUI-1
C0805586
UMLS CUI-2
C1264639
Challenge (0 - 6 Hr) - Start date/time of challenge
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
Challenge (0 - 6 Hr) - End time of challenge
Description

Challenge (0 - 6 Hr) - End time of challenge

Data type

time

Alias
UMLS CUI [1,1]
C0805586
UMLS CUI [1,2]
C1522314
Investigational Product (Dose) - Challenge Date and Time (Visit 1, 3, 5)
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
Investigational Product (Dose) - Challenge Date/Time
Description

Investigational Product (Dose) - Challenge Date/Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
UMLS CUI [2,1]
C0805586
UMLS CUI [2,2]
C1264639
Investigational Product - Date/time of dose (Visit 1, 3, 5)
Description

Investigational Product - Date/time of dose (Visit 1, 3, 5)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Investigational Product - Date/time of dose
Description

Investigational Product - Date/time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Investigational Product - Treatment Confirmation (Visit 1, 3, 5)
Description

Investigational Product - Treatment Confirmation (Visit 1, 3, 5)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0087111
UMLS CUI-3
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
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
If subject did not receive the correct treatment, record reason
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
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Similar models

Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product

1 forms
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])
C2985720 (UMLS CUI [2])
Item Group
Randomisation Number (Vsit 1)
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
Provide Randomisation number
Item
Provide Randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Vital Signs - Challenge Date and Time (Visit 1, 3, 5)
C0518766 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Vital Signs - Challenge date/time
Item
Vital Signs - Challenge date/time
datetime
C0518766 (UMLS CUI [1])
C0805586 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item Group
Vital Signs - Start of Challenge (Visit 1, 3, 5)
C0518766 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
Start of Challenge - Actual date/time
Item
Start of Challenge - Actual date/time
datetime
C0805586 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Start of Challenge - Systolic Blood Pressure
Item
Start of Challenge - Systolic Blood Pressure
integer
C0805586 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Start of Challenge - Diastolic Blood Pressure
Item
Start of Challenge - Diastolic Blood Pressure
integer
C0805586 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Start of Challenge - Heart rate
Item
Start of Challenge - Heart rate
integer
C0805586 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Item Group
Nasal Inspection (Visit 1, 3, 5)
C0558826 (UMLS CUI-1)
Challenge date/time
Item
Challenge date/time
datetime
C1272683 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Date/time of Assessment
Item
Date/time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Left Nostril Colour
text
C0475705 (UMLS CUI [1,1])
C1720438 (UMLS CUI [1,2])
Left Nostril Colour
Code List
Left Nostril Colour
CL Item
Normal  (N)
CL Item
Abnormal; Specify colour  (A)
CL Item
Red  (R)
CL Item
Blue  (B)
CL Item
White (W)
Item
Right Nostril colour
text
C0475705 (UMLS CUI [1,1])
C1720679 (UMLS CUI [1,2])
Right Nostril colour
Code List
Right Nostril colour
CL Item
Normal  (N)
CL Item
Abnormal  (A)
CL Item
Red  (R)
CL Item
Blue  (B)
CL Item
White (W)
Item
Left nostril concha media turbinate Swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Left nostril concha media turbinate Swelling
Code List
Left nostril concha media turbinate Swelling
CL Item
Absent  (A)
CL Item
Mild  (M)
CL Item
Severe (S)
Item
Left nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Left nostril concha inferior turbinate swelling
Code List
Left nostril concha inferior turbinate swelling
CL Item
Absent  (A)
CL Item
Mild  (M)
CL Item
Severe (S)
Item
Right nostril concha media turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Right nostril concha media turbinate swelling
Code List
Right nostril concha media turbinate swelling
CL Item
Absent  (A)
CL Item
Mild  (M)
CL Item
Severe (S)
Item
Right nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Right nostril concha inferior turbinate swelling
Code List
Right nostril concha inferior turbinate swelling
CL Item
Absent  (A)
CL Item
Mild  (M)
CL Item
Severe (S)
Item
Left nostril secretions
text
C1720438 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
Left nostril secretions
Code List
Left nostril secretions
CL Item
Absent  (A)
CL Item
Present; specify colour  (P)
CL Item
Clear  (CL)
CL Item
Opaque  (OP)
CL Item
Purulent (PR)
Item
Right nostril secretions
text
C1720679 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
Right nostril secretions
Code List
Right nostril secretions
CL Item
Absent  (A)
CL Item
Present; specify colour  (P)
CL Item
Clear  (CL)
CL Item
Opaque  (OP)
CL Item
Purulent (PR)
Item
Nasal Infection
text
C0555970 (UMLS CUI [1])
Nasal Infection
Code List
Nasal Infection
CL Item
No infection  (N)
CL Item
Viral infection  (V)
CL Item
Bacterial infection (B)
Item
Post Nasal Drip
text
C0032781 (UMLS CUI [1])
Post Nasal Drip
Code List
Post Nasal Drip
CL Item
Absent  (A)
CL Item
Present; specify colour  (P)
CL Item
Clear  (CL)
CL Item
Opaque  (OP)
CL Item
Purulent (PR)
Item
Crusting
text
C0205204 (UMLS CUI [1])
Crusting
Code List
Crusting
CL Item
Absent  (A)
CL Item
Mild  (M)
CL Item
Severe (S)
Item
Signs of Bleeding
text
C0019080 (UMLS CUI [1])
Signs of Bleeding
Code List
Signs of Bleeding
CL Item
No  (N)
CL Item
Yes; Please specify (Y)
Specify signs of bleeding
Item
Specify signs of bleeding
text
C0019080 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)
C0805586 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Challenge (0 - 6 Hr) - Start date/time of challenge
Item
Challenge (0 - 6 Hr) - Start date/time of challenge
datetime
C0805586 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Challenge (0 - 6 Hr) - End time of challenge
Item
Challenge (0 - 6 Hr) - End time of challenge
time
C0805586 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item Group
Investigational Product (Dose) - Challenge Date and Time (Visit 1, 3, 5)
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
Investigational Product (Dose) - Challenge Date/Time
Item
Investigational Product (Dose) - Challenge Date/Time
datetime
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item Group
Investigational Product - Date/time of dose (Visit 1, 3, 5)
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Investigational Product - Date/time of dose
Item
Investigational Product - Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Investigational Product - Treatment Confirmation (Visit 1, 3, 5)
C0304229 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0750484 (UMLS CUI-3)
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If subject did not receive the correct treatment, record reason
Item
If subject did not receive the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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