ID
41885
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 (3)
- 1/27/21 1/27/21 -
- 2/8/21 2/8/21 -
- 2/8/21 2/8/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 8, 2021
DOI
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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)
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
Description
Investigational Product Day 1 - 7
Alias
- UMLS CUI-1
- C0304229
Description
Planned Timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1301732
Description
Investigational Product
Data type
integer
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Investigational Product Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Description
Investigational Prosuct Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Investigational Product Stop Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Description
Investigational Product Dose
Data type
float
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0678766
Description
Investigational Product Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1519795
Description
Treatment Corfirmation Day 1 - 7
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Description
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Description
If subject did not receive the correct treatment, record reason(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Description
Carbon Monoxide Test - Day 6 PM
Alias
- UMLS CUI-1
- C0007018
- UMLS CUI-2
- C0022885
Description
Carbon Monoxide Test - Date sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1302413
Description
Carbon Monoxide Test - Results
Data type
integer
Measurement units
- ppm
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C0587081
Description
Carbon Monoxide Test - Results
Data type
integer
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C0587081
Description
Urine Test for Drugs of Abuse
Alias
- UMLS CUI-1
- C0202274
Description
Urine Test for Drugs of Abuse
Alias
- UMLS CUI-1
- C0202274
Description
Urine Test for Drugs of Abuse
Data type
integer
Alias
- UMLS CUI [1]
- C0202274
Description
Vital Signs - Day 7
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs - Date
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Vital Signs - Planned Relative Time
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Vital Signs - Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Vital Signs - Systolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0871470
Description
Vital Signs - Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0428883
Description
Vital Signs - Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Description
12-Lead ECG - Day 7
Alias
- UMLS CUI-1
- C0430456
Description
Start Date of ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
12-Lead ECG - Planned Relative Time
Data type
integer
Alias
- UMLS CUI [1]
- C0430456
- UMLS CUI [2,1]
- C0439564
- UMLS CUI [2,2]
- C1301732
Description
Start Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
12-Lead ECG - Ventricular Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Description
12-Lead ECG - PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
12-Lead ECG - QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
12-Lead ECG - Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
12-Lead ECG - QTc Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
12-Lead ECG - Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
12-Lead ECG Abnormalities - Day 7
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
12-Lead ECG Abnormalities - Day 7
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
A. Rhythm
Data type
text
Alias
- UMLS CUI [1]
- C0232187
Description
Other abnormal rhythm - Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Description
B. P-Wave and QRS Morphology
Data type
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
Description
Other P-Wave and QRS Morphology - Comment
Data type
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C0947611
Description
C. Conduction
Data type
text
Alias
- UMLS CUI [1]
- C0232217
Description
Other Conduction - Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Description
D. Myocaridal Infarction
Data type
text
Alias
- UMLS CUI [1]
- C0027051
Description
Other Myocardial Infarction - Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Description
E. Depolarisation/ Repolarisation (QRS-T)
Data type
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
Description
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Description
Other abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Description
Other abnormalities - Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Description
Pulmonary Function Test - Day 7
Alias
- UMLS CUI-1
- C0024119
Description
Pulmonary Function Tests - Date
Data type
date
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0011008
Description
Pulmonary Function Test
Data type
integer
Alias
- UMLS CUI [1]
- C0024119
Description
Pulmonary Function Tests - Units
Data type
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C1519795
Description
Pulmonary Function Tests - Planned Relative Time
Data type
integer
Alias
- UMLS CUI [1]
- C0439564
- UMLS CUI [2]
- C0024119
Description
Pulmonary Function Tests - Actual Time of First Reading
Data type
time
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0040223
Description
Pulmonary Function Tests - Reading 1
Data type
float
Measurement units
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Description
Pulmonary Function Tests - Reading 2
Data type
float
Measurement units
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Description
Pulmonary Function Tests - Reading 3
Data type
float
Measurement units
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Similar models
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
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
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C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1301880 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
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C1274040 (UMLS CUI [1,2])
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C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0429098 (UMLS CUI [2])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0948857 (UMLS CUI [1,2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
C0024119 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])