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41969

Beschreibung

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

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  1. 24.02.21 24.02.21 -
  2. 25.02.21 25.02.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. Februar 2021

DOI

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

    Visit 2, 4, 6 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

    Date of Visit
    Beschreibung

    Date of Visit

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

    Date of visit/assessment

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Challenge Date and Time (0-4 Hr)
    Beschreibung

    Challenge Date and Time (0-4 Hr)

    Alias
    UMLS CUI-1
    C0805586
    UMLS CUI-2
    C1264639
    Start date/time of challenge
    Beschreibung

    Start date/time of challenge

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0805586
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [2,1]
    C0805586
    UMLS CUI [2,2]
    C1301880
    End time of challenge
    Beschreibung

    End time of challenge

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0805586
    UMLS CUI [1,2]
    C1522314
    Pulmonary Function Tests - Challenge Date and Time
    Beschreibung

    Pulmonary Function Tests - Challenge Date and Time

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C1264639
    Pulmonary Function Tests - Challenge date/time
    Beschreibung

    Pulmonary Function Tests - Challenge date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0805586
    UMLS CUI [1,3]
    C1264639
    Pulmonary Function Tests - Start of Challenge
    Beschreibung

    Pulmonary Function Tests - Start of Challenge

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    Pulmonary Function Tests - Date/time of test
    Beschreibung

    Pulmonary Function Tests - Date/time of test

    Datentyp

    datetime

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

    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

    Datentyp

    integer

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

    Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - 1 hr Post Challenge Start
    Beschreibung

    Pulmonary Function Tests - 1 hr Post Challenge Start

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    UMLS CUI-4
    C0231290
    Pulmonary Function Tests - Time of test
    Beschreibung

    Pulmonary Function Tests - Time of test

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0040223
    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

    Datentyp

    integer

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

    Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - 2 hr Post Challenge Start
    Beschreibung

    Pulmonary Function Tests - 2 hr Post Challenge Start

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    UMLS CUI-4
    C0231290
    Pulmonary Function Tests - Time of test
    Beschreibung

    Pulmonary Function Tests - Time of test

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0040223
    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

    Datentyp

    integer

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

    Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - 3 hr Post Challenge Start
    Beschreibung

    Pulmonary Function Tests - 3 hr Post Challenge Start

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    UMLS CUI-4
    C0231290
    Pulmonary Function Tests - Time of test
    Beschreibung

    Pulmonary Function Tests - Time of test

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0040223
    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

    Datentyp

    integer

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

    Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - 4 hr Post Challenge Start
    Beschreibung

    Pulmonary Function Tests - 4 hr Post Challenge Start

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    UMLS CUI-4
    C0231290
    Pulmonary Function Tests - Time of test
    Beschreibung

    Pulmonary Function Tests - Time of test

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0040223
    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

    Datentyp

    integer

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

    Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
    Beschreibung

    Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

    Datentyp

    integer

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Nasal Allergen Challenge - Challenge Date and Time
    Beschreibung

    Nasal Allergen Challenge - Challenge Date and Time

    Alias
    UMLS CUI-1
    C0028429
    UMLS CUI-2
    C0002092
    UMLS CUI-3
    C0805586
    UMLS CUI-4
    C1264639
    Challenge date/time
    Beschreibung

    Challenge date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0805586
    UMLS CUI [1,2]
    C1264639
    Nasal Allergen Challenge - Start of Challenge
    Beschreibung

    Nasal Allergen Challenge - Start of Challenge

    Alias
    UMLS CUI-1
    C0028429
    UMLS CUI-2
    C0002092
    UMLS CUI-3
    C0805586
    Nasal Allergen Challenge - Date and time of assessment
    Beschreibung

    Nasal Allergen Challenge - Date and time of assessment

    Datentyp

    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
    Nasal Allergen Challenge - Nasal blockage
    Beschreibung

    Nasal Allergen Challenge - Nasal blockage

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C0027429
    Nasal Allergen Challenge - Rhinorrhea
    Beschreibung

    Nasal Allergen Challenge - Rhinorrhea

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C1260880
    Nasal Allergen Challenge - Nasal itching
    Beschreibung

    Nasal Allergen Challenge - Nasal itching

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C0850060
    Nasal Allergen Challenge - Sneezing
    Beschreibung

    Nasal Allergen Challenge - Sneezing

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C0037383
    Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)
    Beschreibung

    Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C3533163
    Nasal Allergen Challenge
    Beschreibung

    Nasal Allergen Challenge

    Alias
    UMLS CUI-1
    C0028429
    UMLS CUI-2
    C0002092
    UMLS CUI-3
    C0805586
    Nasal Allergen Challenge - Timepoint
    Beschreibung

    Nasal Allergen Challenge - Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C2348792
    Nasal Allergen Challenge - Time of assessment
    Beschreibung

    Nasal Allergen Challenge - Time of assessment

    Datentyp

    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
    Nasal Allergen Challenge - Nasal blockage
    Beschreibung

    Nasal Allergen Challenge - Nasal blockage

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C0027429
    Nasal Allergen Challenge - Rhinorrhea
    Beschreibung

    Nasal Allergen Challenge - Rhinorrhea

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C1260880
    Nasal Allergen Challenge - Nasal itching
    Beschreibung

    Nasal Allergen Challenge - Nasal itching

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C0850060
    Nasal Allergen Challenge - Sneezing
    Beschreibung

    Nasal Allergen Challenge - Sneezing

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C0037383
    Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)
    Beschreibung

    Nasal Allergen Challenge - Total Nasal Symptom Score (TNSS)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0002092
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C3533163
    Nasal Airflow Resistance - Challenge Date and Time
    Beschreibung

    Nasal Airflow Resistance - Challenge Date and Time

    Alias
    UMLS CUI-1
    C0028429
    UMLS CUI-2
    C0199498
    UMLS CUI-3
    C0805586
    UMLS CUI-4
    C1264639
    Nasal Airflow Resistance - Challenge date/time
    Beschreibung

    Nasal Airflow Resistance - Challenge date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [1,3]
    C0805586
    Nasal Airflow Resistance - 30 Min Post-Challenge
    Beschreibung

    Nasal Airflow Resistance - 30 Min Post-Challenge

    Alias
    UMLS CUI-1
    C0028429
    UMLS CUI-2
    C0199498
    UMLS CUI-3
    C0805586
    UMLS CUI-4
    C0231290
    Nasal Airflow Resistance - Date and time of assessment
    Beschreibung

    Nasal Airflow Resistance - Date and time of assessment

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [2,1]
    C0805586
    UMLS CUI [2,2]
    C2985720
    UMLS CUI [2,3]
    C1264639
    Nasal Airflow Resistance - Left Nostril (150 Pa)
    Beschreibung

    Nasal Airflow Resistance - Left Nostril (150 Pa)

    Datentyp

    integer

    Maßeinheiten
    • mL/s
    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [2]
    C1720438
    mL/s
    Nasal Airflow Resistance - Right Nostril (150 Pa)
    Beschreibung

    Nasal Airflow Resistance - Right Nostril (150 Pa)

    Datentyp

    integer

    Maßeinheiten
    • mL/s
    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [2]
    C1720679
    mL/s
    Nasal Airflow Resistance
    Beschreibung

    Nasal Airflow Resistance

    Alias
    UMLS CUI-1
    C0028429
    UMLS CUI-2
    C0199498
    UMLS CUI-3
    C0805586
    Nasal Airflow Resistance - Timepoint
    Beschreibung

    Nasal Airflow Resistance - Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [1,3]
    C0805586
    UMLS CUI [2]
    C2348792
    Nasal Airflow Resistance - Time of assessment
    Beschreibung

    Nasal Airflow Resistance - Time of assessment

    Datentyp

    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
    Nasal Airflow Resistance - Left Nostril (150 Pa)
    Beschreibung

    Nasal Airflow Resistance - Left Nostril (150 Pa)

    Datentyp

    integer

    Maßeinheiten
    • mL/s
    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [2]
    C1720438
    mL/s
    Nasal Airflow Resistance - Right Nostril (150 Pa)
    Beschreibung

    Nasal Airflow Resistance - Right Nostril (150 Pa)

    Datentyp

    integer

    Maßeinheiten
    • mL/s
    Alias
    UMLS CUI [1,1]
    C0028429
    UMLS CUI [1,2]
    C0199498
    UMLS CUI [2]
    C1720679
    mL/s
    Nasal Secretions - Challenge Date and Time
    Beschreibung

    Nasal Secretions - Challenge Date and Time

    Alias
    UMLS CUI-1
    C1546724
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C1264639
    Placebo Challenge Date/Time
    Beschreibung

    Placebo Challenge Date/Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0032042
    UMLS CUI [1,2]
    C0805586
    UMLS CUI [1,3]
    C1264639
    Nasal Secretions - Start of Challenge
    Beschreibung

    Nasal Secretions - Start of Challenge

    Alias
    UMLS CUI-1
    C1546724
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    Actual start date and time
    Beschreibung

    Actual start date and time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1301880
    Nasal secretion weight
    Beschreibung

    Nasal secretion weight

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C1546724
    UMLS CUI [1,2]
    C0043100
    Nasal Secretions
    Beschreibung

    Nasal Secretions

    Alias
    UMLS CUI-1
    C1546724
    Nasal Secretions - Challenge Start Timepoint
    Beschreibung

    Nasal Secretions - Challenge Start Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1546724
    UMLS CUI [2]
    C0805586
    UMLS CUI [3]
    C0808070
    UMLS CUI [4]
    C2348792
    Actual start time
    Beschreibung

    Actual start time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    Nasal secretion weight
    Beschreibung

    Nasal secretion weight

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C1546724
    UMLS CUI [1,2]
    C0043100
    VAS - Challenge Date and Time
    Beschreibung

    VAS - Challenge Date and Time

    Alias
    UMLS CUI-1
    C2732809
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C1264639
    Challenge date/time
    Beschreibung

    Challenge date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0805586
    UMLS CUI [1,2]
    C1264639
    VAS - Dosing Date and Time
    Beschreibung

    VAS - Dosing Date and Time

    Alias
    UMLS CUI-1
    C2732809
    UMLS CUI-2
    C0439565
    UMLS CUI-3
    C0178602
    UMLS CUI-4
    C1264639
    Dosing date/time
    Beschreibung

    Dosing date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    VAS - Start of Challenge
    Beschreibung

    VAS - Start of Challenge

    Alias
    UMLS CUI-1
    C2732809
    UMLS CUI-2
    C0805586
    UMLS CUI-3
    C0808070
    Actual date/time
    Beschreibung

    Actual date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Severity of your nasal congestion symptoms
    Beschreibung

    Severity of your nasal congestion symptoms

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0027424
    UMLS CUI [1,2]
    C0439793
    VAS
    Beschreibung

    VAS

    Alias
    UMLS CUI-1
    C2732809
    VAS - Timepoint
    Beschreibung

    VAS - Timepoint

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2732809
    UMLS CUI [1,2]
    C2348792
    Actual time
    Beschreibung

    Actual time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Severity of your nasal congestion symptoms
    Beschreibung

    Severity of your nasal congestion symptoms

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0027424
    UMLS CUI [1,2]
    C0439793

    Ähnliche Modelle

    Visit 2, 4, 6 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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
    Challenge Date and Time (0-4 Hr)
    C0805586 (UMLS CUI-1)
    C1264639 (UMLS CUI-2)
    Start date/time of challenge
    Item
    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])
    End time of challenge
    Item
    End time of challenge
    time
    C0805586 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item Group
    Pulmonary Function Tests - Challenge Date and Time
    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])
    Item Group
    Pulmonary Function Tests - Start of Challenge
    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])
    Item Group
    Pulmonary Function Tests - 1 hr Post Challenge Start
    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])
    Item Group
    Pulmonary Function Tests - 2 hr Post Challenge Start
    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])
    Item Group
    Pulmonary Function Tests - 3 hr Post Challenge Start
    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])
    Item Group
    Pulmonary Function Tests - 4 hr Post Challenge Start
    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])
    Item Group
    Nasal Allergen Challenge - Challenge Date and Time
    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])
    Item Group
    Nasal Allergen Challenge - Start of Challenge
    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])
    Item Group
    Nasal Allergen Challenge
    C0028429 (UMLS CUI-1)
    C0002092 (UMLS CUI-2)
    C0805586 (UMLS CUI-3)
    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])
    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)
    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])
    Item Group
    Nasal Airflow Resistance - Challenge Date and Time
    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])
    Item Group
    Nasal Airflow Resistance - 30 Min Post-Challenge
    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 [2,1])
    C2985720 (UMLS CUI [2,2])
    C1264639 (UMLS CUI [2,3])
    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])
    Item Group
    Nasal Airflow Resistance
    C0028429 (UMLS CUI-1)
    C0199498 (UMLS CUI-2)
    C0805586 (UMLS CUI-3)
    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])
    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)
    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])
    Item Group
    Nasal Secretions - Challenge Date and Time
    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])
    Item Group
    Nasal Secretions - Start of Challenge
    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])
    Item Group
    Nasal Secretions
    C1546724 (UMLS CUI-1)
    Item
    Nasal Secretions - Challenge Start Timepoint
    integer
    C1546724 (UMLS CUI [1])
    C0805586 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    C2348792 (UMLS CUI [4])
    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)
    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])
    Item Group
    VAS - Challenge Date and Time
    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])
    Item Group
    VAS - Dosing Date and Time
    C2732809 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    C1264639 (UMLS CUI-4)
    Dosing date/time
    Item
    Dosing date/time
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item Group
    VAS - Start of Challenge
    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])
    Item Group
    VAS
    C2732809 (UMLS CUI-1)
    Item
    VAS - Timepoint
    integer
    C2732809 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    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)
    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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