ID
44593
Beschrijving
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
Trefwoorden
Versies (2)
- 21-12-18 21-12-18 -
- 27-09-21 27-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
27 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Eligibility criteria
- StudyEvent: ODM
Beschrijving
Eligibility criteria
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Gender, Age, informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
- UMLS CUI [3]
- C0021430
Beschrijving
AST, ALT, alkaline phosphatase, bilirubin
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C0201850
- UMLS CUI [4]
- C0201913
Beschrijving
Healthy subject (medical history, physical examination, laboratory tests, cardiac monitoring)
Datatype
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
Beschrijving
BMI
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Informed consent, protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0525058
Beschrijving
number of pack years = (number of cigarettes per day/20) x number of years smoked)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0337672
- UMLS CUI [2]
- C1277691
Beschrijving
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).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0522055
- UMLS CUI [1,3]
- C2985739
Beschrijving
No clinically significant abnormalities in 24 hour Holter ECG
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0013801
- UMLS CUI [1,3]
- C2985739
Beschrijving
FEV1
Datatype
boolean
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
Use of inhaler
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0021461
Beschrijving
Inclusion criteria for female
Alias
- UMLS CUI-1
- C0086287
- UMLS CUI-2
- C1512693
Beschrijving
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).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3831118
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0282402
- UMLS CUI [2,1]
- C3829127
- 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
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2,1]
- C1524063
- UMLS CUI [2,2]
- C0700589
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Medical interview, physical examination or screening investigations
Datatype
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
Beschrijving
Clinically concerning arrhythmias
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0003811
- UMLS CUI [1,2]
- C2699424
- UMLS CUI [1,3]
- C0013801
Beschrijving
Blood pressure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Heart rate
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Medically significant disease, family history of QT prolongation, of early/sudden cardiac death/early cardiovascular disease.
Datatype
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
Beschrijving
Current/chronic history of liver disease, hepatic or biliary abnormalities
Datatype
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
Beschrijving
History of breathing problems, no normal lung function
Datatype
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
Beschrijving
Upper/lower respiratory tract Infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0041912
- UMLS CUI [2]
- C0149725
Beschrijving
Pregnant females, positive urine/serum hCG test
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2,1]
- C0430060
- UMLS CUI [2,2]
- C1446409
Beschrijving
Lactating females
Datatype
boolean
Alias
- UMLS CUI [1]
- C2828358
Beschrijving
positive Hepatitis B surface antigen, positive Hepatitis C antibody
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Beschrijving
Positive test for HIV antibody
Datatype
boolean
Alias
- UMLS CUI [1]
- C0920548
Beschrijving
Taken inhaled, intranasal or topical steroids
Datatype
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
Beschrijving
Positive carbon monoxide (CO) or alcohol breath test
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [2,1]
- C0202306
- UMLS CUI [2,2]
- C1446409
Beschrijving
Positive urine cotinine test
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C1446409
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0560579
Beschrijving
Receiving an investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2348568
Beschrijving
Exposure to chemical entities
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0449788
Beschrijving
Use of prescription or non-prescription drugs (vitamins, herbal and dietary supplements including St Johns Wort)
Datatype
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
Beschrijving
Taken of oral corticosteroids
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0442027
- UMLS CUI [1,3]
- C0149783
Beschrijving
Sensitivity of study medication, history of drug/other allergy
Datatype
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
Beschrijving
Milk protein allergy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C3889086
Beschrijving
Donation of blood or blood products
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0005794
- UMLS CUI [2]
- C2348568
Beschrijving
No protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0525058
Beschrijving
Mentally or legally incapacitated
Datatype
boolean
Alias
- UMLS CUI [1]
- C1306341
- UMLS CUI [2,1]
- C0683673
- UMLS CUI [2,2]
- C0332268
Beschrijving
Consumption of seville oranges, pummelos, grapefruit
Datatype
boolean
Alias
- UMLS CUI [1]
- C0330922
- UMLS CUI [2]
- C1006780
- UMLS CUI [3]
- C0995150
Beschrijving
Hypersensitivity to corticosteroids
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0001617
Beschrijving
Hypersensitivity to beta-2 agonist/sympathomimetic drug/ inhalation powder (lactose, magnesium stearate).
Datatype
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])
C0522055 (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])
C3829127 (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])