ID
41968
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 (2)
- 2/23/21 2/23/21 -
- 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 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS
Description
Pulmonary Function Tests - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Description
Pulmonary Function Tests - Dosing Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Description
Pulmonary Function Tests - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Description
Pulmonary Function Tests - Date/time of test
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C1264639
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - 1 hr Post Challenge Start (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
- UMLS CUI-4
- C0231290
Description
Pulmonary Function Tests - Time of test
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - 2 hr Post Challenge Start (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
- UMLS CUI-4
- C0231290
Description
Pulmonary Function Tests - Time of test
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - 3 hr Post Challenge Start (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
- UMLS CUI-4
- C0231290
Description
Pulmonary Function Tests - Time of test
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - 4 hr Post Challenge Start (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
- UMLS CUI-4
- C0231290
Description
Pulmonary Function Tests - Time of test
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - 5 hr Post Challenge Start (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
- UMLS CUI-4
- C0231290
Description
Pulmonary Function Tests - Time of test
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - 6 hr Post Challenge Start (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
- UMLS CUI-4
- C0231290
Description
Pulmonary Function Tests - Time of test
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Data type
integer
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Nasal Allergen Challenge - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0002092
- UMLS CUI-3
- C0805586
- UMLS CUI-4
- C1264639
Description
Nasal Allergen Challenge - Dosing Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0002092
- UMLS CUI-3
- C0805586
- UMLS CUI-4
- C0178602
- UMLS CUI-5
- C1264639
Description
Nasal Allergen Challenge - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0002092
- UMLS CUI-3
- C0805586
Description
Nasal Allergen Challenge - Date and time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2,1]
- C2985720
- UMLS CUI [2,2]
- C1264639
Description
Nasal Allergen Challenge - Nasal blockage
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C0027429
Description
Nasal Allergen Challenge - Rhinorrhea
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C1260880
Description
Nasal Allergen Challenge - Nasal itching
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C0850060
Description
Nasal Allergen Challenge - Sneezing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C0037383
Description
Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C3533163
Description
Nasal Allergen Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0002092
- UMLS CUI-3
- C0805586
Description
Nasal Allergen Challenge - Timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C2348792
Description
Nasal Allergen Challenge - Time of assessment
Data type
time
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2,1]
- C1516048
- UMLS CUI [2,2]
- C0040223
Description
Nasal Allergen Challenge - Nasal blockage
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C0027429
Description
Nasal Allergen Challenge - Rhinorrhea
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C1260880
Description
Nasal Allergen Challenge - Nasal itching
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C0850060
Description
Nasal Allergen Challenge - Sneezing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C0037383
Description
Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C3533163
Description
Nasal Airflow Resistance - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0199498
- UMLS CUI-3
- C0805586
- UMLS CUI-4
- C1264639
Description
Nasal Airflow Resistance - 30 Min Post-Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0199498
- UMLS CUI-3
- C0805586
- UMLS CUI-4
- C0231290
Description
Nasal Airflow Resistance - Date and time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2,1]
- C2985720
- UMLS CUI [2,2]
- C1264639
Description
Nasal Airflow Resistance - Left Nostril (150 Pa)
Data type
integer
Measurement units
- mL/s
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [2]
- C1720438
Description
Nasal Airflow Resistance - Right Nostril (150 Pa)
Data type
integer
Measurement units
- mL/s
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [2]
- C1720679
Description
Nasal Airflow Resistance (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0199498
- UMLS CUI-3
- C0805586
Description
Nasal Airflow Resistance - Timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2]
- C2348792
Description
Nasal Airflow Resistance - Time of assessment
Data type
time
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C0805586
- UMLS CUI [2,1]
- C1516048
- UMLS CUI [2,2]
- C0040223
Description
Nasal Airflow Resistance - Left Nostril (150 Pa)
Data type
integer
Measurement units
- mL/s
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [2]
- C1720438
Description
Nasal Airflow Resistance - Right Nostril (150 Pa)
Data type
integer
Measurement units
- mL/s
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [2]
- C1720679
Description
Nasal Secretions - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C1546724
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Description
Nasal Secretions - Dosing Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C1546724
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0178602
- UMLS CUI-4
- C1264639
Description
Nasal Secretions - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C1546724
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Description
Nasal Secretions (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C1546724
Description
Nasal Secretions - Challenge Start Timepoint
Data type
integer
Alias
- UMLS CUI [1]
- C1546724
- UMLS CUI [2]
- C0805586
- UMLS CUI [3]
- C0808070
- UMLS CUI [4]
- C2348792
Description
Actual start time
Data type
time
Alias
- UMLS CUI [1]
- C1301880
Description
Nasal secretion weight
Data type
float
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0043100
Description
VAS - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C2732809
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Description
VAS - Dosing Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C2732809
- UMLS CUI-2
- C0439565
- UMLS CUI-3
- C0178602
- UMLS CUI-4
- C1264639
Description
VAS - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C2732809
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Description
VAS (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C2732809
Description
VAS - Timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C2732809
- UMLS CUI [1,2]
- C2348792
Description
Actual time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Severity of your nasal congestion symptoms
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027424
- UMLS CUI [1,2]
- C0439793
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C0002092 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0027429 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
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C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0850060 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0037383 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C3533163 (UMLS CUI [2])
C0002092 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
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C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0027429 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1260880 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0850060 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0037383 (UMLS CUI [2])
C0002092 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C3533163 (UMLS CUI [2])
C0199498 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0199498 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C0231290 (UMLS CUI-4)
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [2])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [2])
C0199498 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
C0199498 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [2])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [2])
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0805586 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0805586 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
C1264639 (UMLS CUI [1,2])
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C1301880 (UMLS CUI [1,2])
C0043100 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
C2348792 (UMLS CUI [4])
C0043100 (UMLS CUI [1,2])
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C1264639 (UMLS CUI [1,2])
C0439565 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
C1264639 (UMLS CUI [1,2])
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
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