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ID

41978

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

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Versions (1)
  1. 3/11/21 3/11/21 -
Copyright Holder

GlaxoSmithKline

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March 11, 2021

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Creative Commons BY 4.0
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    Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356

    English

    Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

    1 forms  
    Total Nasal Symptom Scores
    Description

    Total Nasal Symptom Scores

    Alias
    UMLS CUI-1
    C3533163
    UMLS CUI-2
    C0028429
    Date and time of assessment
    Description

    Date and time of assessment

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1264639
    Nasal blockage
    Description

    Nasal blockage

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027429
    Rhinorrhea
    Description

    Rhinorrhea

    Data type

    text

    Alias
    UMLS CUI [1]
    C1260880
    Nasal itching
    Description

    Nasal itching

    Data type

    text

    Alias
    UMLS CUI [1]
    C0850060
    Sneezing
    Description

    Sneezing

    Data type

    text

    Alias
    UMLS CUI [1]
    C0037383
    Total Nasal Symptom Scores
    Description

    Total Nasal Symptom Scores

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3533163
    UMLS CUI [1,2]
    C0028429
    VAS
    Description

    VAS

    Alias
    UMLS CUI-1
    C2732809
    Actual date/time
    Description

    Actual date/time

    Data type

    datetime

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

    Severity of your nasal congestion symptoms

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027424
    UMLS CUI [1,2]
    C0439793
    Pharmacogenetic Research Consent
    Description

    Pharmacogenetic Research Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    Date informed consent obtained for PGx-Pharmacogenetic research
    Description

    Date informed consent obtained for PGx-Pharmacogenetic research

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    Record date sample taken
    Description

    Record date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Reason for consent has not been obtained
    Description

    Reason for consent has not been obtained

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0566251
    Specify other reason for consent has not been obtained
    Description

    Specify other reason for consent has not been obtained

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0566251
    UMLS CUI [2]
    C0205394
    UMLS CUI [3]
    C2348235
    Pharmacogenetic Research Withdrawal of Consent
    Description

    Pharmacogenetic Research Withdrawal of Consent

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C0031325
    Has subject withdrawn consent for PGx research?
    Description

    Has subject withdrawn consent for PGx research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    Date informed consent withdrawn
    Description

    Date informed consent withdrawn

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0011008
    Has a request been made for sample destruction?
    Description

    Has a request been made for sample destruction?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    Check reason for sample destruction
    Description

    Check reason for sample destruction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0392360
    Specify other reason for sample destruction
    Description

    Specify other reason for sample destruction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [2]
    C0205394
    UMLS CUI [3]
    C2348235
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    Similar models

    Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Total Nasal Symptom Scores
    C3533163 (UMLS CUI-1)
    C0028429 (UMLS CUI-2)
    Date and time of assessment
    Item
    Date and time of assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Nasal blockage
    Item
    Nasal blockage
    text
    C0027429 (UMLS CUI [1])
    Rhinorrhea
    Item
    Rhinorrhea
    text
    C1260880 (UMLS CUI [1])
    Nasal itching
    Item
    Nasal itching
    text
    C0850060 (UMLS CUI [1])
    Sneezing
    Item
    Sneezing
    text
    C0037383 (UMLS CUI [1])
    Total Nasal Symptom Scores
    Item
    Total Nasal Symptom Scores
    text
    C3533163 (UMLS CUI [1,1])
    C0028429 (UMLS CUI [1,2])
    Item Group
    VAS
    C2732809 (UMLS CUI-1)
    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
    text
    C0027424 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    Item Group
    Pharmacogenetic Research Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Date informed consent obtained for PGx-Pharmacogenetic research
    Item
    Date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Item
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Record date sample taken
    Item
    Record date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Reason for consent has not been obtained
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Reason for consent has not been obtained
    Code List
    Reason for consent has not been obtained
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    Specify other reason for consent has not been obtained
    Item
    Specify other reason for consent has not been obtained
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    Item Group
    Pharmacogenetic Research Withdrawal of Consent
    C1707492 (UMLS CUI-1)
    C0031325 (UMLS CUI-2)
    Has subject withdrawn consent for PGx research?
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    Date informed consent withdrawn
    Item
    Date informed consent withdrawn
    date
    C1707492 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    Check reason for sample destruction
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Check reason for sample destruction
    Code List
    Check reason for sample destruction
    CL Item
    Subject withdrew consent for PGx (3)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (Z)
    Specify other reason for sample destruction
    Item
    Specify other reason for sample destruction
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
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