0 Bedömningar
ID

41751

Beskrivning

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Nyckelord

Versioner (1)
  1. 2021-01-12 2021-01-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

12 januari 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

    Engelsk

    Eligibility Question

    1 Formulär  
    1. StudyEvent: ODM
      1. Eligibility Question
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Eligibility Question
    Beskrivning

    Eligibility Question

    Alias
    UMLS CUI-1
    C1516637
    Did the subject meet all the entry criteria?
    Beskrivning

    Did the subject meet all the entry criteria?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Healthy; defined as individuals who are free of significant cardiac, pulmonary gastrointestinal, hepatic, renal, haematologic, neurological and psychiatric disease as determined by medical history, physical examination and clinical chemistry/haematology/urinalysis investigation.
    Beskrivning

    Healthy; defined as individuals who are free of significant cardiac, pulmonary gastrointestinal, hepatic, renal, haematologic, neurological and psychiatric disease as determined by medical history, physical examination and clinical chemistry/haematology/urinalysis investigation.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3898900
    UMLS CUI [2]
    C0018799
    UMLS CUI [3]
    C0024115
    UMLS CUI [4]
    C0017178
    UMLS CUI [5]
    C0023895
    UMLS CUI [6]
    C0022658
    UMLS CUI [7]
    C0018939
    UMLS CUI [8]
    C0027765
    UMLS CUI [9]
    C0004936
    UMLS CUI [10]
    C0262926
    UMLS CUI [11]
    C0031809
    UMLS CUI [12]
    C0008000
    UMLS CUI [13]
    C0018941
    UMLS CUI [14]
    C0042014
    Male or Female (non child bearing potential only). A female is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant defined as documented tubal ligation or hysterectomy), including any female who is post-menopausal. For the purposes of this study, post-menopausal is defined as 1 year without menses.
    Beskrivning

    Male Gender, Self Report | Females; Childbearing Potential | Childbearing Potential; Absent | Tubal Ligation | Hysterectomy | Postmenopausal state

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1706180
    UMLS CUI [2,1]
    C0086287
    UMLS CUI [2,2]
    C3831118
    UMLS CUI [3]
    C0520483
    UMLS CUI [4]
    C0020699
    UMLS CUI [5]
    C0232970
    Aged 18-65 years
    Beskrivning

    Aged 18-65 years

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Body mass index within range of 19-31kg/m^2
    Beskrivning

    Body mass index within range of 19-31kg/m^2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    A non-smoker for at least the past 12 months with a pack history <= pack years
    Beskrivning

    A non-smoker for at least the past 12 months with a pack history <= pack years

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0337672
    UMLS CUI [2]
    C1277691
    Normal ECG at Screening
    Beskrivning

    Normal ECG at Screening

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Able to provide written informed consent
    Beskrivning

    Able to provide written informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Available to complete the study and all measurements
    Beskrivning

    Available to complete the study and all measurements

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Able to use the inhalation device satisfactorily
    Beskrivning

    Able to use the inhalation device satisfactorily

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0021461
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    As a result of medical interview, physical examination or screening investigations, the responsible physician deems the subject unsuitable for the study.
    Beskrivning

    As a result of medical interview, physical examination or screening investigations, the responsible physician deems the subject unsuitable for the study.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021822
    UMLS CUI [2]
    C0031809
    UMLS CUI [3,1]
    C0220908
    UMLS CUI [3,2]
    C0841577
    UMLS CUI [4]
    C3839996
    The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation
    Beskrivning

    The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013182
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C1301624
    UMLS CUI [3,2]
    C0679823
    The subject has a known hypersensitivity to corticosteroids or the excipients of GW685698X (lactose/COA)
    Beskrivning

    The subject has a known hypersensitivity to corticosteroids or the excipients of GW685698X (lactose/COA)

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0001617
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0015237
    UMLS CUI [3]
    C0022949
    The subject has participated in a study with a new molecular entity during the previous 112 days or any other trial during the previous 84 days
    Beskrivning

    The subject has participated in a study with a new molecular entity during the previous 12 days or any other trial during the previous 84 days

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    The subject has donated a unit of blood within the previous 4 months or intends to donate within 4 months after completing the study.
    Beskrivning

    The subject has donated a unit of blood within the previous 4 months or intends to donate within 4 months after completing the study.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
    Beskrivning

    The subject has taken oral corticosteroids less than 8 weeks before the screening visit.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0442027
    UMLS CUI [1,3]
    C0149783
    The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
    Beskrivning

    The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2065041
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C0038317
    UMLS CUI [2,2]
    C0001560
    UMLS CUI [2,3]
    C0332185
    UMLS CUI [3,1]
    C2064827
    UMLS CUI [3,2]
    C0332185
    The subject is currently taking regular (or a course of) medication whether prescribed or not, within 14 days of the first dose of study medication.
    Beskrivning

    The subject is currently taking regular (or a course of) medication whether prescribed or not, within 14 days of the first dose of study medication.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0205272
    Drink on average more than 4 units of alcohol per day (3 units for females) and no more than 21 units of alcohol a week (14 units for females) (one unit=125mL wine or 25 mL spirits or 250mL normal strength lager).
    Beskrivning

    Drink on average more than 4 units of alcohol per day (3 units for females) and no more than 21 units of alcohol a week (14 units for females) (one unit=125mL wine or 25 mL spirits or 250mL normal strength lager).

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    UMLS CUI [2]
    C0560578
    UMLS CUI [3]
    C0560579
    The subject has a history of breathing problems in adult life (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1 and PEFR) will be performed to confirm normal lung function parameters (>=90% predicted).
    Beskrivning

    The subject has a history of breathing problems in adult life (i.e. history of asthmatic symptomatology).Screening lung function tests (FEV1 and PEFR) will be performed to confirm normal lung function parameters (>=90% predicted).

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0035203
    UMLS CUI [1,3]
    C1254481
    UMLS CUI [2,1]
    C0004096
    UMLS CUI [2,2]
    C1457887
    UMLS CUI [3,1]
    C0024119
    UMLS CUI [3,2]
    C0220908
    UMLS CUI [4]
    C0748133
    The subject has been treated for or diagnosed with depression within six months of screening
    Beskrivning

    The subject has been treated for or diagnosed with depression within six months of screening

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011581
    The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen (test to be taken within 3 months of study start).
    Beskrivning

    The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen (test to be taken within 3 months of study start).

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0281863
    UMLS CUI [2]
    C0149709
    The subject has tested positive for HIV antibodies
    Beskrivning

    The subject has tested positive for HIV antibodies

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019683
    The subject has positive drugs of abuse test at screening or when randomly tested during the study.
    Beskrivning

    The subject has positive drugs of abuse test at screening or when randomly tested during the study.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C1446409
    The subject works night-shifts that may change pattern during the study.
    Beskrivning

    The subject works night-shifts that may change pattern during the study.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0555008
    Tillbaka till toppen

    Similar models

    Eligibility Question

    1 Formulär
    1. StudyEvent: ODM
      1. Eligibility Question
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Eligibility Question
    C1516637 (UMLS CUI-1)
    Did the subject meet all the entry criteria?
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Healthy; defined as individuals who are free of significant cardiac, pulmonary gastrointestinal, hepatic, renal, haematologic, neurological and psychiatric disease as determined by medical history, physical examination and clinical chemistry/haematology/urinalysis investigation.
    Item
    Healthy; defined as individuals who are free of significant cardiac, pulmonary gastrointestinal, hepatic, renal, haematologic, neurological and psychiatric disease as determined by medical history, physical examination and clinical chemistry/haematology/urinalysis investigation.
    boolean
    C3898900 (UMLS CUI [1])
    C0018799 (UMLS CUI [2])
    C0024115 (UMLS CUI [3])
    C0017178 (UMLS CUI [4])
    C0023895 (UMLS CUI [5])
    C0022658 (UMLS CUI [6])
    C0018939 (UMLS CUI [7])
    C0027765 (UMLS CUI [8])
    C0004936 (UMLS CUI [9])
    C0262926 (UMLS CUI [10])
    C0031809 (UMLS CUI [11])
    C0008000 (UMLS CUI [12])
    C0018941 (UMLS CUI [13])
    C0042014 (UMLS CUI [14])
    Male Gender, Self Report | Females; Childbearing Potential | Childbearing Potential; Absent | Tubal Ligation | Hysterectomy | Postmenopausal state
    Item
    Male or Female (non child bearing potential only). A female is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant defined as documented tubal ligation or hysterectomy), including any female who is post-menopausal. For the purposes of this study, post-menopausal is defined as 1 year without menses.
    boolean
    C1706180 (UMLS CUI [1])
    C0086287 (UMLS CUI [2,1])
    C3831118 (UMLS CUI [2,2])
    C0520483 (UMLS CUI [3])
    C0020699 (UMLS CUI [4])
    C0232970 (UMLS CUI [5])
    Aged 18-65 years
    Item
    Aged 18-65 years
    boolean
    C0001779 (UMLS CUI [1])
    Body mass index within range of 19-31kg/m^2
    Item
    Body mass index within range of 19-31kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    A non-smoker for at least the past 12 months with a pack history <= pack years
    Item
    A non-smoker for at least the past 12 months with a pack history <= pack years
    boolean
    C0337672 (UMLS CUI [1])
    C1277691 (UMLS CUI [2])
    Normal ECG at Screening
    Item
    Normal ECG at Screening
    boolean
    C0522054 (UMLS CUI [1])
    Able to provide written informed consent
    Item
    Able to provide written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Available to complete the study and all measurements
    Item
    Available to complete the study and all measurements
    boolean
    C1321605 (UMLS CUI [1])
    Able to use the inhalation device satisfactorily
    Item
    Able to use the inhalation device satisfactorily
    boolean
    C0085732 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0021461 (UMLS CUI [1,3])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    As a result of medical interview, physical examination or screening investigations, the responsible physician deems the subject unsuitable for the study.
    Item
    As a result of medical interview, physical examination or screening investigations, the responsible physician deems the subject unsuitable for the study.
    boolean
    C0021822 (UMLS CUI [1])
    C0031809 (UMLS CUI [2])
    C0220908 (UMLS CUI [3,1])
    C0841577 (UMLS CUI [3,2])
    C3839996 (UMLS CUI [4])
    The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation
    Item
    The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation
    boolean
    C0013182 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C1301624 (UMLS CUI [3,1])
    C0679823 (UMLS CUI [3,2])
    The subject has a known hypersensitivity to corticosteroids or the excipients of GW685698X (lactose/COA)
    Item
    The subject has a known hypersensitivity to corticosteroids or the excipients of GW685698X (lactose/COA)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0001617 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0015237 (UMLS CUI [2,2])
    C0022949 (UMLS CUI [3])
    The subject has participated in a study with a new molecular entity during the previous 12 days or any other trial during the previous 84 days
    Item
    The subject has participated in a study with a new molecular entity during the previous 112 days or any other trial during the previous 84 days
    boolean
    C2348568 (UMLS CUI [1])
    The subject has donated a unit of blood within the previous 4 months or intends to donate within 4 months after completing the study.
    Item
    The subject has donated a unit of blood within the previous 4 months or intends to donate within 4 months after completing the study.
    boolean
    C0005794 (UMLS CUI [1])
    The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
    Item
    The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
    boolean
    C0332185 (UMLS CUI [1,1])
    C0442027 (UMLS CUI [1,2])
    C0149783 (UMLS CUI [1,3])
    The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
    Item
    The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
    boolean
    C2065041 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0038317 (UMLS CUI [2,1])
    C0001560 (UMLS CUI [2,2])
    C0332185 (UMLS CUI [2,3])
    C2064827 (UMLS CUI [3,1])
    C0332185 (UMLS CUI [3,2])
    The subject is currently taking regular (or a course of) medication whether prescribed or not, within 14 days of the first dose of study medication.
    Item
    The subject is currently taking regular (or a course of) medication whether prescribed or not, within 14 days of the first dose of study medication.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
    Drink on average more than 4 units of alcohol per day (3 units for females) and no more than 21 units of alcohol a week (14 units for females) (one unit=125mL wine or 25 mL spirits or 250mL normal strength lager).
    Item
    Drink on average more than 4 units of alcohol per day (3 units for females) and no more than 21 units of alcohol a week (14 units for females) (one unit=125mL wine or 25 mL spirits or 250mL normal strength lager).
    boolean
    C0001948 (UMLS CUI [1])
    C0560578 (UMLS CUI [2])
    C0560579 (UMLS CUI [3])
    The subject has a history of breathing problems in adult life (i.e. history of asthmatic symptomatology).Screening lung function tests (FEV1 and PEFR) will be performed to confirm normal lung function parameters (>=90% predicted).
    Item
    The subject has a history of breathing problems in adult life (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1 and PEFR) will be performed to confirm normal lung function parameters (>=90% predicted).
    boolean
    C0262926 (UMLS CUI [1,1])
    C0035203 (UMLS CUI [1,2])
    C1254481 (UMLS CUI [1,3])
    C0004096 (UMLS CUI [2,1])
    C1457887 (UMLS CUI [2,2])
    C0024119 (UMLS CUI [3,1])
    C0220908 (UMLS CUI [3,2])
    C0748133 (UMLS CUI [4])
    The subject has been treated for or diagnosed with depression within six months of screening
    Item
    The subject has been treated for or diagnosed with depression within six months of screening
    boolean
    C0011581 (UMLS CUI [1])
    The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen (test to be taken within 3 months of study start).
    Item
    The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen (test to be taken within 3 months of study start).
    boolean
    C0281863 (UMLS CUI [1])
    C0149709 (UMLS CUI [2])
    The subject has tested positive for HIV antibodies
    Item
    The subject has tested positive for HIV antibodies
    boolean
    C0019683 (UMLS CUI [1])
    The subject has positive drugs of abuse test at screening or when randomly tested during the study.
    Item
    The subject has positive drugs of abuse test at screening or when randomly tested during the study.
    boolean
    C0373483 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    The subject works night-shifts that may change pattern during the study.
    Item
    The subject works night-shifts that may change pattern during the study.
    boolean
    C0555008 (UMLS CUI [1])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial