ID
44593
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Nyckelord
Versioner (2)
- 2018-12-21 2018-12-21 -
- 2021-09-27 2021-09-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 september 2021
DOI
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Licens
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
Beskrivning
Eligibility criteria
Alias
- UMLS CUI-1
- C1516637
Beskrivning
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
Gender, Age, informed consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
- UMLS CUI [3]
- C0021430
Beskrivning
AST, ALT, alkaline phosphatase, bilirubin
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C0201850
- UMLS CUI [4]
- C0201913
Beskrivning
Healthy subject (medical history, physical examination, laboratory tests, cardiac monitoring)
Datatyp
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
Beskrivning
BMI
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
Informed consent, protocol compliance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0525058
Beskrivning
number of pack years = (number of cigarettes per day/20) x number of years smoked)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0337672
- UMLS CUI [2]
- C1277691
Beskrivning
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).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0522055
- UMLS CUI [1,3]
- C2985739
Beskrivning
No clinically significant abnormalities in 24 hour Holter ECG
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0013801
- UMLS CUI [1,3]
- C2985739
Beskrivning
FEV1
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0748133
Beskrivning
Use of inhaler
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0021461
Beskrivning
Inclusion criteria for female
Alias
- UMLS CUI-1
- C0086287
- UMLS CUI-2
- C1512693
Beskrivning
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).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3831118
Beskrivning
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)
Datatyp
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
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2,1]
- C1524063
- UMLS CUI [2,2]
- C0700589
Beskrivning
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Medical interview, physical examination or screening investigations
Datatyp
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
Beskrivning
Clinically concerning arrhythmias
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003811
- UMLS CUI [1,2]
- C2699424
- UMLS CUI [1,3]
- C0013801
Beskrivning
Blood pressure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Heart rate
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Medically significant disease, family history of QT prolongation, of early/sudden cardiac death/early cardiovascular disease.
Datatyp
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
Beskrivning
Current/chronic history of liver disease, hepatic or biliary abnormalities
Datatyp
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
Beskrivning
History of breathing problems, no normal lung function
Datatyp
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
Beskrivning
Upper/lower respiratory tract Infection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0041912
- UMLS CUI [2]
- C0149725
Beskrivning
Pregnant females, positive urine/serum hCG test
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2,1]
- C0430060
- UMLS CUI [2,2]
- C1446409
Beskrivning
Lactating females
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2828358
Beskrivning
positive Hepatitis B surface antigen, positive Hepatitis C antibody
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Beskrivning
Positive test for HIV antibody
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0920548
Beskrivning
Taken inhaled, intranasal or topical steroids
Datatyp
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
Beskrivning
Positive carbon monoxide (CO) or alcohol breath test
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [2,1]
- C0202306
- UMLS CUI [2,2]
- C1446409
Beskrivning
Positive urine cotinine test
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C1446409
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0560579
Beskrivning
Receiving an investigational product
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2348568
Beskrivning
Exposure to chemical entities
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0449788
Beskrivning
Use of prescription or non-prescription drugs (vitamins, herbal and dietary supplements including St Johns Wort)
Datatyp
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
Beskrivning
Taken of oral corticosteroids
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0442027
- UMLS CUI [1,3]
- C0149783
Beskrivning
Sensitivity of study medication, history of drug/other allergy
Datatyp
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
Beskrivning
Milk protein allergy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C3889086
Beskrivning
Donation of blood or blood products
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0005794
- UMLS CUI [2]
- C2348568
Beskrivning
No protocol compliance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0525058
Beskrivning
Mentally or legally incapacitated
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1306341
- UMLS CUI [2,1]
- C0683673
- UMLS CUI [2,2]
- C0332268
Beskrivning
Consumption of seville oranges, pummelos, grapefruit
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0330922
- UMLS CUI [2]
- C1006780
- UMLS CUI [3]
- C0995150
Beskrivning
Hypersensitivity to corticosteroids
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0001617
Beskrivning
Hypersensitivity to beta-2 agonist/sympathomimetic drug/ inhalation powder (lactose, magnesium stearate).
Datatyp
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])