ID
44593
Descripción
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
Palabras clave
Versiones (2)
- 21/12/18 21/12/18 -
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
27 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Eligibility criteria
Alias
- UMLS CUI-1
- C1516637
Descripción
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
Gender, Age, informed consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
- UMLS CUI [3]
- C0021430
Descripción
AST, ALT, alkaline phosphatase, bilirubin
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C0201850
- UMLS CUI [4]
- C0201913
Descripción
Healthy subject (medical history, physical examination, laboratory tests, cardiac monitoring)
Tipo de datos
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
Descripción
BMI
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1305855
Descripción
Informed consent, protocol compliance
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0525058
Descripción
number of pack years = (number of cigarettes per day/20) x number of years smoked)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0337672
- UMLS CUI [2]
- C1277691
Descripción
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).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0522055
- UMLS CUI [1,3]
- C2985739
Descripción
No clinically significant abnormalities in 24 hour Holter ECG
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0013801
- UMLS CUI [1,3]
- C2985739
Descripción
FEV1
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0748133
Descripción
Use of inhaler
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0021461
Descripción
Inclusion criteria for female
Alias
- UMLS CUI-1
- C0086287
- UMLS CUI-2
- C1512693
Descripción
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).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3831118
Descripción
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)
Tipo de datos
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
Descripción
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)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2,1]
- C1524063
- UMLS CUI [2,2]
- C0700589
Descripción
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Medical interview, physical examination or screening investigations
Tipo de datos
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
Descripción
Clinically concerning arrhythmias
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0003811
- UMLS CUI [1,2]
- C2699424
- UMLS CUI [1,3]
- C0013801
Descripción
Blood pressure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005823
Descripción
Heart rate
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0018810
Descripción
Medically significant disease, family history of QT prolongation, of early/sudden cardiac death/early cardiovascular disease.
Tipo de datos
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
Descripción
Current/chronic history of liver disease, hepatic or biliary abnormalities
Tipo de datos
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
Descripción
History of breathing problems, no normal lung function
Tipo de datos
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
Descripción
Upper/lower respiratory tract Infection
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0041912
- UMLS CUI [2]
- C0149725
Descripción
Pregnant females, positive urine/serum hCG test
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2,1]
- C0430060
- UMLS CUI [2,2]
- C1446409
Descripción
Lactating females
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2828358
Descripción
positive Hepatitis B surface antigen, positive Hepatitis C antibody
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Descripción
Positive test for HIV antibody
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0920548
Descripción
Taken inhaled, intranasal or topical steroids
Tipo de datos
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
Descripción
Positive carbon monoxide (CO) or alcohol breath test
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [2,1]
- C0202306
- UMLS CUI [2,2]
- C1446409
Descripción
Positive urine cotinine test
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C1446409
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0560579
Descripción
Receiving an investigational product
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2348568
Descripción
Exposure to chemical entities
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0449788
Descripción
Use of prescription or non-prescription drugs (vitamins, herbal and dietary supplements including St Johns Wort)
Tipo de datos
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
Descripción
Taken of oral corticosteroids
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0442027
- UMLS CUI [1,3]
- C0149783
Descripción
Sensitivity of study medication, history of drug/other allergy
Tipo de datos
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
Descripción
Milk protein allergy
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C3889086
Descripción
Donation of blood or blood products
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0005794
- UMLS CUI [2]
- C2348568
Descripción
No protocol compliance
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0525058
Descripción
Mentally or legally incapacitated
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1306341
- UMLS CUI [2,1]
- C0683673
- UMLS CUI [2,2]
- C0332268
Descripción
Consumption of seville oranges, pummelos, grapefruit
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0330922
- UMLS CUI [2]
- C1006780
- UMLS CUI [3]
- C0995150
Descripción
Hypersensitivity to corticosteroids
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0001617
Descripción
Hypersensitivity to beta-2 agonist/sympathomimetic drug/ inhalation powder (lactose, magnesium stearate).
Tipo de datos
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])