ID

41968

Beschrijving

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

Trefwoorden

Klinische Studie [Dokumenttyp]

Respiratory Function Tests

Visual Analog Scale

J30.4

23-02-21 23-02-21 -
25-02-21 25-02-21 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

25 februari 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356

model
Details

Visit 1, 3, 5 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

1 Formulieren

StudyEvent: ODM
1. Visit 1, 3, 5 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Challenge Date and Time (Visit 1, 3, 5)

Item Group

Challenge Date and Time (Visit 1, 3, 5)

C0805586 (UMLS CUI-1)
C1264639 (UMLS CUI-2)

Challenge Date and Time

Item

Challenge Date and Time

datetime

C0805586 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Pulmonary Function Tests - Challenge Date and Time (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - Challenge Date and Time (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)

Pulmonary Function Tests - Challenge date/time

Item

Pulmonary Function Tests - Challenge date/time

datetime

C0024119 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])

Pulmonary Function Tests - Dosing Date and Time (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - Dosing Date and Time (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)

Dosing date/time

Item

Dosing date/time

datetime

C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Pulmonary Function Tests - Start of Challenge (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - Start of Challenge (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)

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])

Pulmonary Function Tests - 1 hr Post Challenge Start (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - 1 hr Post Challenge Start (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Pulmonary Function Tests - Time of test

Item

Pulmonary Function Tests - Time of test

time

C0024119 (UMLS CUI [1,1])
C0040223 (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])

Pulmonary Function Tests - 2 hr Post Challenge Start (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - 2 hr Post Challenge Start (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Pulmonary Function Tests - Time of test

Item

Pulmonary Function Tests - Time of test

time

C0024119 (UMLS CUI [1,1])
C0040223 (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])

Pulmonary Function Tests - 3 hr Post Challenge Start (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - 3 hr Post Challenge Start (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Pulmonary Function Tests - Time of test

Item

Pulmonary Function Tests - Time of test

time

C0024119 (UMLS CUI [1,1])
C0040223 (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])

Pulmonary Function Tests - 4 hr Post Challenge Start (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - 4 hr Post Challenge Start (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Pulmonary Function Tests - Time of test

Item

Pulmonary Function Tests - Time of test

time

C0024119 (UMLS CUI [1,1])
C0040223 (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])

Pulmonary Function Tests - 5 hr Post Challenge Start (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - 5 hr Post Challenge Start (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Pulmonary Function Tests - Time of test

Item

Pulmonary Function Tests - Time of test

time

C0024119 (UMLS CUI [1,1])
C0040223 (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])

Pulmonary Function Tests - 6 hr Post Challenge Start (Visit 1, 3, 5)

Item Group

Pulmonary Function Tests - 6 hr Post Challenge Start (Visit 1, 3, 5)

C0024119 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Pulmonary Function Tests - Time of test

Item

Pulmonary Function Tests - Time of test

time

C0024119 (UMLS CUI [1,1])
C0040223 (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])

Nasal Allergen Challenge - Challenge Date and Time (Visit 1, 3, 5)

Item Group

Nasal Allergen Challenge - Challenge Date and Time (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0002092 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C1264639 (UMLS CUI-4)

Challenge date/time

Item

Challenge date/time

datetime

C0805586 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Nasal Allergen Challenge - Dosing Date and Time (Visit 1, 3, 5)

Item Group

Nasal Allergen Challenge - Dosing Date and Time (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0002092 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C1264639 (UMLS CUI-5)

Dosing date/time

Item

Dosing date/time

datetime

C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Nasal Allergen Challenge - Start of Challenge (Visit 1, 3, 5)

Item Group

Nasal Allergen Challenge - Start of Challenge (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0002092 (UMLS CUI-2)
C0805586 (UMLS CUI-3)

Nasal Allergen Challenge - Date and time of assessment

Item

Nasal Allergen Challenge - Date and time of assessment

datetime

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])

Nasal Allergen Challenge - Nasal blockage

Item

Nasal Allergen Challenge - Nasal blockage

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0027429 (UMLS CUI [2])

Nasal Allergen Challenge - Rhinorrhea

Item

Nasal Allergen Challenge - Rhinorrhea

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1260880 (UMLS CUI [2])

Nasal Allergen Challenge - Nasal itching

Item

Nasal Allergen Challenge - Nasal itching

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0850060 (UMLS CUI [2])

Nasal Allergen Challenge - Sneezing

Item

Nasal Allergen Challenge - Sneezing

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0037383 (UMLS CUI [2])

Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)

Item

Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C3533163 (UMLS CUI [2])

Nasal Allergen Challenge (Visit 1, 3, 5)

Item Group

Nasal Allergen Challenge (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0002092 (UMLS CUI-2)
C0805586 (UMLS CUI-3)

Nasal Allergen Challenge - Timepoint

Item

Nasal Allergen Challenge - Timepoint

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])

Nasal Allergen Challenge - Timepoint

Code List

Nasal Allergen Challenge - Timepoint

CL Item

20 Min Post-Challenge (1)

CL Item

40 Min Post-Challenge (2)

CL Item

1 Hr Post-Challenge (3)

CL Item

1 Hr 20 Min Post-Challenge (4)

CL Item

1 Hr 40 Min Post-Challenge (5)

CL Item

2 Hr (Pre-Dose) (6)

CL Item

2 Hr 20 Min Post-Challenge (7)

CL Item

2 Hr 40 Min Post-Challenge (8)

CL Item

3 Hr Post-Challenge (9)

CL Item

3 Hr 20 Min Post-Challenge (10)

CL Item

3 Hr 40 Min Post-Challenge (11)

CL Item

4 Hr Post-Challenge (12)

CL Item

4 Hr 20 Min Post-Challenge (13)

CL Item

4 Hr 40 Min Post-Challenge (14)

CL Item

5 hr Post-Challenge (15)

CL Item

5 Hr 20 Min Post-Challenge (16)

CL Item

5 Hr 40 Min Post-Challenge (17)

CL Item

6Hr Post-Challenge (18)

Nasal Allergen Challenge - Time of assessment

Item

Nasal Allergen Challenge - Time of assessment

time

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])

Nasal Allergen Challenge - Nasal blockage

Item

Nasal Allergen Challenge - Nasal blockage

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0027429 (UMLS CUI [2])

Nasal Allergen Challenge - Rhinorrhea

Item

Nasal Allergen Challenge - Rhinorrhea

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1260880 (UMLS CUI [2])

Nasal Allergen Challenge - Nasal itching

Item

Nasal Allergen Challenge - Nasal itching

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0850060 (UMLS CUI [2])

Nasal Allergen Challenge - Sneezing

Item

Nasal Allergen Challenge - Sneezing

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0037383 (UMLS CUI [2])

Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)

Item

Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)

integer

C0028429 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C3533163 (UMLS CUI [2])

Nasal Airflow Resistance - Challenge Date and Time (Visit 1, 3, 5)

Item Group

Nasal Airflow Resistance - Challenge Date and Time (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0199498 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C1264639 (UMLS CUI-4)

Nasal Airflow Resistance - Challenge date/time

Item

Nasal Airflow Resistance - Challenge date/time

datetime

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])

Nasal Airflow Resistance - 30 Min Post-Challenge (Visit 1, 3, 5)

Item Group

Nasal Airflow Resistance - 30 Min Post-Challenge (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0199498 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C0231290 (UMLS CUI-4)

Nasal Airflow Resistance - Date and time of assessment

Item

Nasal Airflow Resistance - Date and time of assessment

datetime

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])

Nasal Airflow Resistance - Left Nostril (150 Pa)

Item

Nasal Airflow Resistance - Left Nostril (150 Pa)

integer

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [2])

Nasal Airflow Resistance - Right Nostril (150 Pa)

Item

Nasal Airflow Resistance - Right Nostril (150 Pa)

integer

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [2])

Nasal Airflow Resistance (Visit 1, 3, 5)

Item Group

Nasal Airflow Resistance (Visit 1, 3, 5)

C0028429 (UMLS CUI-1)
C0199498 (UMLS CUI-2)
C0805586 (UMLS CUI-3)

Nasal Airflow Resistance - Timepoint

Item

Nasal Airflow Resistance - Timepoint

integer

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])

Nasal Airflow Resistance - Timepoint

Code List

Nasal Airflow Resistance - Timepoint

CL Item

1 Hr 30 Min Post-Challenge (1)

CL Item

2 Hr 30 Min Post-Challenge (2)

CL Item

3 Hr 30 Min Post-Challenge (3)

CL Item

4 Hr 30 Min Post-Challenge (4)

CL Item

5 Hr 30 Min Post-Challenge (5)

Nasal Airflow Resistance - Time of assessment

Item

Nasal Airflow Resistance - Time of assessment

time

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])

Nasal Airflow Resistance - Left Nostril (150 Pa)

Item

Nasal Airflow Resistance - Left Nostril (150 Pa)

integer

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [2])

Nasal Airflow Resistance - Right Nostril (150 Pa)

Item

Nasal Airflow Resistance - Right Nostril (150 Pa)

integer

C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [2])

Nasal Secretions - Challenge Date and Time (Visit 1, 3, 5)

Item Group

Nasal Secretions - Challenge Date and Time (Visit 1, 3, 5)

C1546724 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)

Placebo Challenge Date/Time

Item

Placebo Challenge Date/Time

datetime

C0032042 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])

Nasal Secretions - Dosing Date and Time (Visit 1, 3, 5)

Item Group

Nasal Secretions - Dosing Date and Time (Visit 1, 3, 5)

C1546724 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1264639 (UMLS CUI-4)

Dosing Date and Time

Item

Dosing Date and Time

datetime

C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Nasal Secretions - Start of Challenge (Visit 1, 3, 5)

Item Group

Nasal Secretions - Start of Challenge (Visit 1, 3, 5)

C1546724 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)

Actual start date and time

Item

Actual start date and time

datetime

C0808070 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])

Nasal secretion weight

Item

Nasal secretion weight

float

C1546724 (UMLS CUI [1,1])
C0043100 (UMLS CUI [1,2])

Nasal Secretions (Visit 1, 3, 5)

Item Group

Nasal Secretions (Visit 1, 3, 5)

C1546724 (UMLS CUI-1)

Nasal Secretions - Challenge Start Timepoint

Item

Nasal Secretions - Challenge Start Timepoint

integer

C1546724 (UMLS CUI [1])
C0805586 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
C2348792 (UMLS CUI [4])

Nasal Secretions - Challenge Start Timepoint

Code List

Nasal Secretions - Challenge Start Timepoint

CL Item

1 Hr Post-Challenge Start (1)

CL Item

2 Hr Post-Challenge Start (Pre-Dose) (2)

CL Item

3 Hr Post-Challenge Start (3)

CL Item

4 Hr Post-Challenge Start (4)

CL Item

5 Hr Post-Challenge Start (5)

CL Item

6 Hr Post-Challenge Start (6)

Actual start time

Item

Actual start time

time

C1301880 (UMLS CUI [1])

Nasal secretion weight

Item

Nasal secretion weight

float

C1546724 (UMLS CUI [1,1])
C0043100 (UMLS CUI [1,2])

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

Item Group

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

C2732809 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)

Challenge date/time

Item

Challenge date/time

datetime

C0805586 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

VAS - Dosing Date and Time (Visit 1, 3, 5)

Item Group

VAS - Dosing Date and Time (Visit 1, 3, 5)

C2732809 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1264639 (UMLS CUI-4)

Dosing Date and Time

Item

Dosing Date and Time

datetime

C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

VAS - Start of Challenge (Visit 1, 3, 5)

Item Group

VAS - Start of Challenge (Visit 1, 3, 5)

C2732809 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)

Actual date/time

Item

Actual date/time

datetime

C1264639 (UMLS CUI [1])

Severity of your nasal congestion symptoms

Item

Severity of your nasal congestion symptoms

integer

C0027424 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])

VAS (Visit 1, 3, 5)

Item Group

VAS (Visit 1, 3, 5)

C2732809 (UMLS CUI-1)

VAS - Timepoint

Item

VAS - Timepoint

integer

C2732809 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])

VAS - Timepoint

Code List

VAS - Timepoint

CL Item

20 Min Post-Challenge (1)

CL Item

40 Min Post-Challenge (2)

CL Item

1 Hr Post-Challenge (3)

CL Item

1 Hr 20 Min Post-Challenge (4)

CL Item

1 Hr 40 Min Post-Challenge (5)

CL Item

2 Hr Post-Challenge (Pre-Dose) (6)

CL Item

2 Hr 20 Min Post-Challenge (7)

CL Item

2 Hr 40 Min Post-Challenge (8)

CL Item

3 Hr Post-Challenge (9)

CL Item

3 Hr 20 Min Post-Challenge (10)

CL Item

3 Hr 40 Min Post-Challenge (11)

CL Item

4 Hr Post-Challenge (12)

CL Item

4 Hr 20 Min Post-Challenge (13)

CL Item

4 Hr 40 Min Post-Challenge (14)

CL Item

5 Hr Post-Challenge (15)

CL Item

5 Hr 20 Min Post-Challenge (16)

CL Item

5 Hr 40 Min Post-Challenge (17)

CL Item

6 Hr Post-Challenge (18)

Actual time

Item

Actual time

time

C0040223 (UMLS CUI [1])

Severity of your nasal congestion symptoms

Item

Severity of your nasal congestion symptoms

integer

C0027424 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])

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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356

Visit 1, 3, 5 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

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