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ID
41885
Beschreibung
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
Stichworte
Versionen (3)
- 27.01.21 27.01.21 -
- 08.02.21 08.02.21 -
- 08.02.21 08.02.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. Februar 2021
DOI
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Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)
Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test
Ähnliche Modelle
Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Investigational Product Day 1 - 7
C0304229 (UMLS CUI-1)
Item
Planned Timepoint
integer
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
AM (1)
CL Item
PM (2)
CL Item
Diskus A (1)
CL Item
Diskus B (2)
CL Item
Diskus C (3)
Investigational Product Start Date
Item
Investigational Product Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Investigational Product Start Time
Item
Investigational Product Start Time
time
C0304229 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Investigational Prosuct Stop Date
Item
Investigational Prosuct Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Investigational Product Stop Time
Item
Investigational Product Stop Time
time
C0304229 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Investigational Product Dose
Item
Investigational Product Dose
float
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,2])
Item
Investigational Product Units
text
C0304229 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
Inhalation (INH)
Item Group
Treatment Corfirmation Day 1 - 7
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
C0750484 (UMLS CUI-2)
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
If subject did not receive the correct treatment, record reason(s)
Item
If subject did not receive the correct treatment, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Carbon Monoxide Test - Day 6 PM
C0007018 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Carbon Monoxide Test - Date sample taken
Item
Carbon Monoxide Test - Date sample taken
date
C0007018 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Carbon Monoxide Test - Results
Item
Carbon Monoxide Test - Results
integer
C0007018 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Carbon Monoxide Test - Results
integer
C0007018 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Urine Test for Drugs of Abuse - Date sample taken
Item
Urine Test for Drugs of Abuse - Date sample taken
date
C0202274 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
CL Item
Amphetamines (1)
CL Item
Cocaine (2)
CL Item
Methamphetamine (3)
CL Item
Opiates (Morphine) (4)
CL Item
Cannabinoids (Cannabis) (5)
CL Item
Barbiturates (6)
CL Item
Methadone (7)
CL Item
Benzodiazepines (8)
Vital Signs - Date
Item
Vital Signs - Date
date
C2826644 (UMLS CUI [1])
Item
Vital Signs - Planned Relative Time
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Pre-dose (1)
CL Item
1h (2)
CL Item
2h (3)
CL Item
4h (4)
CL Item
6h (5)
CL Item
8h (6)
CL Item
12h (7)
CL Item
24h (8)
Vital Signs - Actual Time
Item
Vital Signs - Actual Time
time
C2826762 (UMLS CUI [1])
Vital Signs - Systolic Blood Pressure
Item
Vital Signs - Systolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
Vital Signs - Diastolic Blood Pressure
Item
Vital Signs - Diastolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
Vital Signs - Heart Rate
Item
Vital Signs - Heart Rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
12-Lead ECG - Planned Relative Time
integer
C0430456 (UMLS CUI [1])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
CL Item
Pre-Dose (1)
CL Item
1h (2)
CL Item
2h (3)
CL Item
4h (4)
CL Item
6h (5)
CL Item
8h (6)
CL Item
12h (7)
CL Item
24h (8)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
12-Lead ECG - Ventricular Rate
Item
12-Lead ECG - Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
12-Lead ECG - PR Interval
Item
12-Lead ECG - PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
12-Lead ECG - QRS Duration
Item
12-Lead ECG - QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
12-Lead ECG - Uncorrected QT Interval
Item
12-Lead ECG - Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
12-Lead ECG - QTc Interval
Item
12-Lead ECG - QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
Item
12-Lead ECG - Result
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities - Day 7
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities - Day 7
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40 - 50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30 - 39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <=100 beats/min) (A5)
CL Item
Junctional rhythm (A26)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
Idioventricular rhythm (heart rate <100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsade de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial pacemaker (A16)
CL Item
Other abnormal rhythm (A99)
Other abnormal rhythm - Comment
Item
Other abnormal rhythm - Comment
text
C0232187 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
B. P-Wave and QRS Morphology
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C0429098 (UMLS CUI [2])
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
Other P-Wave and QRS Morphology - Comment
Item
Other P-Wave and QRS Morphology - Comment
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
CL Item
First degree AV block (PR interval >200msec) (C1)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 ms (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
Other Conduction - Comment
Item
Other Conduction - Comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
CL Item
Myocaridal infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non-Q wave (D20)
CL Item
Other myocardial infarction (D98)
Other Myocardial Infarction - Comment
Item
Other Myocardial Infarction - Comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
E. Depolarisation/ Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0948857 (UMLS CUI [1,2])
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST elevation-pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T-wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/inversion (D17)
CL Item
Other depolarisatoin/repolarisation (D99)
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Item
Other Depolarisation/ Repolarisation (QRS-T) - Comment
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Other abnormalities (E99)
Other abnormalities - Comment
Item
Other abnormalities - Comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Pulmonary Function Tests - Date
Item
Pulmonary Function Tests - Date
date
C0024119 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
CL Item
PEFR (1)
Item
Pulmonary Function Tests - Units
integer
C0024119 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
CL Item
L/min (1)
Item
Pulmonary Function Tests - Planned Relative Time
integer
C0439564 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
C0024119 (UMLS CUI [2])
Code List
Pulmonary Function Tests - Planned Relative Time
CL Item
Pre-Dose (1)
CL Item
1h (2)
CL Item
4h (3)
CL Item
12h (4)
CL Item
24h (5)
Pulmonary Function Tests - Actual Time of First Reading
Item
Pulmonary Function Tests - Actual Time of First Reading
time
C0024119 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
Pulmonary Function Tests - Reading 1
Item
Pulmonary Function Tests - Reading 1
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
Pulmonary Function Tests - Reading 2
Item
Pulmonary Function Tests - Reading 2
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
Pulmonary Function Tests - Reading 3
Item
Pulmonary Function Tests - Reading 3
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])