Information:
Fel:
ID
29727
Beskrivning
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Screening
Nyckelord
Versioner (2)
- 2018-04-05 2018-04-05 -
- 2018-04-16 2018-04-16 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 april 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849
Similar models
Screening
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject identifier
Item
Subject identifier
integer
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
Item
If Female: Record child-bearing potential
integer
C1960468 (UMLS CUI [1])
CL Item
Post-menopausal (1)
CL Item
sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian, Central/South Asian Heritage (3)
CL Item
Asian, East Asian Heritage (4)
CL Item
Aslan, Japanese Heritage (5)
CL Item
Asian, South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White, Arabic/North African Heritage (8)
CL Item
White, White/Caucasian/European Heritage (9)
serum pregnancy test
Item
serum pregnancy test positive?
boolean
C0430060 (UMLS CUI [1])
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Medical condition
Item
Medical condition, Diagnosis
text
C0011900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Item
Please specify condition status
integer
C0012634 (UMLS CUI [1,1])
C3176928 (UMLS CUI [1,2])
C3176928 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
current smoker (2)
(Comment:en)
CL Item
former smoker (3)
(Comment:en)
CL Item
never smoked (1)
last smoke
Item
if former smoker, when did the subjet last smoke?
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken Drug and Alcohol Screen
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken Drug and Alcohol Screen
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabis metabolites
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
C0870883 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time sample taken Haematology
Item
Time sample taken Haematology
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit (HCT)
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
text
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
text
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
text
C3544087 (UMLS CUI [1])
Monocyte count (absolute)
Item
Monocyte count (absolute)
text
C0200637 (UMLS CUI [1])
Eosinophil count (absolute)
Item
Eosinophil count (absolute)
text
C0200638 (UMLS CUI [1])
Basophil count (absolute)
Item
Basophil count (absolute)
text
C0200641 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Sample Taken
Item
Time Sample Taken Clinical Chemistry
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Creatine Phosphokinase (CPK)
Item
Creatine Phosphokinase (CPK)
float
C0201973 (UMLS CUI [1])
Serum FSH
Item
Serum FSH
float
C0455276 (UMLS CUI [1])
Serum estradiol
Item
Serum estradiol
float
C0474672 (UMLS CUI [1])
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
C0600091 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Date sample taken Urinalysis
Item
Date sample taken Urinalysis
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time sample taken Urinalysis
Item
Time sample taken Urinalysis
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urine Specific Gravity
Item
Urine Specific Gravity
float
C0202517 (UMLS CUI [1])
Urine pH
Item
Urine pH
float
C0042044 (UMLS CUI [1])
Urine Glucose
Item
Urine Glucose
float
C0004076 (UMLS CUI [1])
Urine Protein
Item
Urine Protein
float
C0262923 (UMLS CUI [1])
Hematuria
Item
Urine Blood
float
C0018965 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
Urine Ketones
Item
Urine Ketones
float
C1991100 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Red Blood Cells
Item
Red Blood Cells
float
C0014772 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
White blood cells
Item
White blood cells
float
C0023508 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Hyaline casts
Item
Hyaline casts
float
C0427894 (UMLS CUI [1])
Granular casts
Item
Granular casts
float
C2697521 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Cellular casts
Item
Cellular casts
float
C2699157 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Crystals
Item
Crystals
float
C1287304 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0459958 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Item
Number of measurement
integer
C0430456 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal, Not clinically significant (2)
CL Item
Abnormal, Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form If the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Inclusion Criteria
Item
Inclusion Criteria, please select all boxes corresponding to violations of any inclusion/exclusion criteria
integer
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Subject Identification
Item
Subject Identification
text
C2348585 (UMLS CUI [1])
Randomisation number
Item
Record randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
CL Item
Sequence 1 (ABC) (1)
CL Item
Sequence 2 (BCA) (2)
CL Item
Sequence 3 (CAB) (3)
CL Item
Sequence 4 (BAC) (4)
CL Item
Sequence 5 (ACB) (5)
CL Item
Sequence 6 (CBA) (6)