ID
33739
Description
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 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 The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the eligibility criteria. It has to be filled in for screening.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Keywords
Versions (2)
- 12/21/18 12/21/18 -
- 9/27/21 9/27/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 21, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Eligibility criteria
- StudyEvent: ODM
Description
Eligibility criteria
Alias
- UMLS CUI-1
- C1516637
Description
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Description
Gender, Age, informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
- UMLS CUI [3]
- C0021430
Description
AST, ALT, alkaline phosphatase, bilirubin
Data type
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C0201850
- UMLS CUI [4]
- C0201913
Description
Healthy subject (medical history, physical examination, laboratory tests, cardiac monitoring)
Data type
boolean
Alias
- UMLS CUI [1]
- C1708335
- UMLS CUI [2]
- C0262926
- UMLS CUI [3]
- C0022885
- UMLS CUI [4]
- C0150496
- UMLS CUI [5,1]
- C1298908
- UMLS CUI [5,2]
- C1704258
- UMLS CUI [5,3]
- C0332300
- UMLS CUI [5,4]
- C3845945
- UMLS CUI [5,5]
- C0184661
Description
BMI
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
Informed consent, protocol compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0525058
Description
number of pack years = (number of cigarettes per day/20) x number of years smoked)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0337672
- UMLS CUI [2]
- C1277691
Description
Including the followlng specific requirements: Ventricular rate >= 40 beats per minute PR lnterval <= 210 msec Q waves < 30 msec (up to 5O ms permitted in lead III only) QRS interval to be >= 60msec and <120msec The wave forms must enable the QT interval to be clearly defined QTcF interval must be < 450 msec (machine or manual reading).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C1832603
- UMLS CUI [1,3]
- C2985739
Description
No clinically significant abnormalities in 24 hour Holter ECG
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0013801
- UMLS CUI [1,3]
- C2985739
Description
FEV1
Data type
boolean
Alias
- UMLS CUI [1]
- C0748133
Description
Use of inhaler
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0021461
Description
Inclusion criteria for female
Alias
- UMLS CUI-1
- C0086287
- UMLS CUI-2
- C1512693
Description
Non-childbearing potential is defined as: pre-menopausal remales with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (< 140 pmol/l) Is confirmatory).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3831118
Description
For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a cootraceptive method. Contraceptive Methods with a Failure Rate of < 1% : • Oral contraceptive, either combined or progestogen alone • Injectable progestogen • Implants of levonorgestrel • Estrogenic vaginal ring • Percutaneous contraceptive patches • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. • Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
Data type
boolean
Alias
- UMLS CUI [1]
- C0282402
- UMLS CUI [2,1]
- C1513126
- UMLS CUI [2,2]
- C0205370
- UMLS CUI [2,3]
- C1524063
- UMLS CUI [2,4]
- C0700589
- UMLS CUI [3,1]
- C1444662
- UMLS CUI [3,2]
- C0282402
Description
Contraceptive Methods with a Failure Rate of < 1% : • Oral contraceptive, either combined or progestogen alone • Injectable progestogen • Implants of levonorgestrel • Estrogenic vaginal ring • Percutaneous contraceptive patches • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. • Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
Data type
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2,1]
- C1524063
- UMLS CUI [2,2]
- C0700589
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Description
Medical interview, physical examination or screening investigations
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0031809
- UMLS CUI [3]
- C1261322
- UMLS CUI [4,1]
- C1512714
- UMLS CUI [4,2]
- C0871010
- UMLS CUI [4,3]
- C0008961
Description
Clinically concerning arrhythmias
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0003811
- UMLS CUI [1,2]
- C2699424
- UMLS CUI [1,3]
- C0013801
Description
Blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Data type
boolean
Alias
- UMLS CUI [1]
- C0018810
Description
Medically significant disease, family history of QT prolongation, of early/sudden cardiac death/early cardiovascular disease.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205476
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0151878
- UMLS CUI [3]
- C2825161
- UMLS CUI [4,1]
- C0241889
- UMLS CUI [4,2]
- C0007222
- UMLS CUI [5,1]
- C0035647
- UMLS CUI [5,2]
- C0008976
- UMLS CUI [5,3]
- C2700391
- UMLS CUI [6,1]
- C0521102
- UMLS CUI [6,2]
- C0008976
- UMLS CUI [6,3]
- C2700391
Description
Current/chronic history of liver disease, hepatic or biliary abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0023895
- UMLS CUI [2]
- C0341439
- UMLS CUI [3]
- C4021780
- UMLS CUI [4]
- C0549613
- UMLS CUI [5,1]
- C0332300
- UMLS CUI [5,2]
- C0017551
- UMLS CUI [6,1]
- C0332300
- UMLS CUI [6,2]
- C0231221
- UMLS CUI [6,3]
- C0008350
Description
History of breathing problems, no normal lung function
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035203
- UMLS CUI [1,3]
- C0033213
- UMLS CUI [2,1]
- C1298908
- UMLS CUI [2,2]
- C0205307
- UMLS CUI [2,3]
- C0024119
- UMLS CUI [2,4]
- C0332185
Description
Upper/lower respiratory tract Infection
Data type
boolean
Alias
- UMLS CUI [1]
- C0041912
- UMLS CUI [2]
- C0149725
Description
Pregnant females, positive urine/serum hCG test
Data type
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2,1]
- C0430060
- UMLS CUI [2,2]
- C1446409
Description
Lactating females
Data type
boolean
Alias
- UMLS CUI [1]
- C2828358
Description
positive Hepatitis B surface antigen, positive Hepatitis C antibody
Data type
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Description
Positive test for HIV antibody
Data type
boolean
Alias
- UMLS CUI [1]
- C0920548
Description
Taken inhaled, intranasal or topical steroids
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C2065041
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0001560
- UMLS CUI [2,3]
- C2064827
- UMLS CUI [3,1]
- C0332185
- UMLS CUI [3,2]
- C2064827
Description
Positive carbon monoxide (CO) or alcohol breath test
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [2,1]
- C0202306
- UMLS CUI [2,2]
- C1446409
Description
Positive urine cotinine test
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C1446409
Description
Regular alcohol consumption is defined as: average weekly Intake of >21 units for males or > 14 units for females One unit is equivalent to 8 g of alcohol: a half-pint (~240 m1) of beer, 1 glass ( 12S ml) of wine or 1 (25 ml) measure of spirits.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0560579
Description
Receiving an investigational product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2348568
Description
Exposure to chemical entities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0449788
Description
Use of prescription or non-prescription drugs (vitamins, herbal and dietary supplements including St Johns Wort)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0013231
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0304227
- UMLS CUI [3,1]
- C0332185
- UMLS CUI [3,2]
- C0042890
- UMLS CUI [4,1]
- C0332185
- UMLS CUI [4,2]
- C1504473
- UMLS CUI [5,1]
- C0332185
- UMLS CUI [5,2]
- C0242295
- UMLS CUI [6,1]
- C0332185
- UMLS CUI [6,2]
- C0936242
Description
Taken of oral corticosteroids
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0442027
- UMLS CUI [1,3]
- C0149783
Description
Sensitivity of study medication, history of drug/other allergy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0013182
- UMLS CUI [3,1]
- C0020517
- UMLS CUI [3,2]
- C0205394
- UMLS CUI [4,1]
- C2348568
- UMLS CUI [4,2]
- C0522473
Description
Milk protein allergy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C3889086
Description
Donation of blood or blood products
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0005794
- UMLS CUI [2]
- C2348568
Description
No protocol compliance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0525058
Description
Mentally or legally incapacitated
Data type
boolean
Alias
- UMLS CUI [1]
- C1306341
- UMLS CUI [2,1]
- C0683673
- UMLS CUI [2,2]
- C0332268
Description
Consumption of seville oranges, pummelos, grapefruit
Data type
boolean
Alias
- UMLS CUI [1]
- C0330922
- UMLS CUI [2]
- C1006780
- UMLS CUI [3]
- C0995150
Description
Hypersensitivity to corticosteroids
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0001617
Description
Hypersensitivity to beta-2 agonist/sympathomimetic drug/ inhalation powder (lactose, magnesium stearate).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C2936789
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0991575
- UMLS CUI [2,3]
- C0304229
- UMLS CUI [3]
- C0022949
- UMLS CUI [4]
- C0126791
Similar models
Eligibility criteria
- StudyEvent: ODM
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0262926 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C0150496 (UMLS CUI [4])
C1298908 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C0332300 (UMLS CUI [5,3])
C3845945 (UMLS CUI [5,4])
C0184661 (UMLS CUI [5,5])
C0525058 (UMLS CUI [2])
C0337672 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
C1832603 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0013801 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
C1512693 (UMLS CUI-2)
C3831118 (UMLS CUI [1,2])
C1513126 (UMLS CUI [2,1])
C0205370 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
C1444662 (UMLS CUI [3,1])
C0282402 (UMLS CUI [3,2])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2])
C1261322 (UMLS CUI [3])
C1512714 (UMLS CUI [4,1])
C0871010 (UMLS CUI [4,2])
C0008961 (UMLS CUI [4,3])
C2699424 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0241889 (UMLS CUI [2,1])
C0151878 (UMLS CUI [2,2])
C2825161 (UMLS CUI [3])
C0241889 (UMLS CUI [4,1])
C0007222 (UMLS CUI [4,2])
C0035647 (UMLS CUI [5,1])
C0008976 (UMLS CUI [5,2])
C2700391 (UMLS CUI [5,3])
C0521102 (UMLS CUI [6,1])
C0008976 (UMLS CUI [6,2])
C2700391 (UMLS CUI [6,3])
C0023895 (UMLS CUI [1,2])
C0341439 (UMLS CUI [2])
C4021780 (UMLS CUI [3])
C0549613 (UMLS CUI [4])
C0332300 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
C0332300 (UMLS CUI [6,1])
C0231221 (UMLS CUI [6,2])
C0008350 (UMLS CUI [6,3])
C0035203 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,3])
C1298908 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0024119 (UMLS CUI [2,3])
C0332185 (UMLS CUI [2,4])
C0149725 (UMLS CUI [2])
C0430060 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0281863 (UMLS CUI [2])
C2065041 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0001560 (UMLS CUI [2,2])
C2064827 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C2064827 (UMLS CUI [3,2])
C1446409 (UMLS CUI [1,2])
C0202306 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C1446409 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [2])
C0013231 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0304227 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C0042890 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C1504473 (UMLS CUI [4,2])
C0332185 (UMLS CUI [5,1])
C0242295 (UMLS CUI [5,2])
C0332185 (UMLS CUI [6,1])
C0936242 (UMLS CUI [6,2])
C0442027 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4,1])
C0522473 (UMLS CUI [4,2])
C3889086 (UMLS CUI [1,2])
C0005794 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0525058 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1006780 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0001617 (UMLS CUI [1,2])
C2936789 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0991575 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
C0022949 (UMLS CUI [3])
C0126791 (UMLS CUI [4])