ID

41751

Description

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

Keywords

Versions (1)
  1. 1/12/21 1/12/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 12, 2021

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License

Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

English

Eligibility Question

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Question
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Description

Eligibility Question

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

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

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.
Description

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.

Data type

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.
Description

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

Data type

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
Description

Aged 18-65 years

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Normal ECG at Screening

Data type

boolean

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

Able to provide written informed consent

Data type

boolean

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

Available to complete the study and all measurements

Data type

boolean

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

Able to use the inhalation device satisfactorily

Data type

boolean

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

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.
Description

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

Data type

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
Description

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

Data type

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)
Description

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

Data type

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
Description

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

Data type

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.
Description

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

Data type

boolean

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

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

Data type

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.
Description

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

Data type

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.
Description

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.

Data type

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).
Description

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).

Data type

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).
Description

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).

Data type

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
Description

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

Data type

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).
Description

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

Data type

boolean

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

The subject has tested positive for HIV antibodies

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0555008
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Similar models

Eligibility Question

1 forms
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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