ID

44593

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)
  1. 12/21/18 12/21/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

English

Eligibility criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Eligibility criteria
Description

Eligibility criteria

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

If No, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Data type

text

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Male or female between 18 and 65 years of age inclusive, at the time of Signing the informed consent.
Description

Gender, Age, informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
AST, ALT, alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
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
Healthy as determined by a responsible and experienced physician, based on a medical evaluation induding medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality of laboratory parameters outside the reference range for the population being studied may be included If the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
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
BMI within the range 18.5-29.0 kg/m2 (inclusive).
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

Informed consent, protocol compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Subjects who are current non-smokers, who have not used any tobacco products in the 6 month period preceding the screening visit, and have a pack history of <= 10 pack years.
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
No significant abnormality on 12-1ead ECG at screening
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]
C0522055
UMLS CUI [1,3]
C2985739
A 24 hour Holter ECG at screening that demonstrates no clinically significant abnormalities or finding that could interfere with interpretation of the study results, when assessed by an appropriately trained and experienced reviewer.
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
FEV1 >= 85% predicted at screening
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
Subjects who are able to use the inhaler satisfactorily
Description

Use of inhaler

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0021461
Inclusion criteria for female
Description

Inclusion criteria for female

Alias
UMLS CUI-1
C0086287
UMLS CUI-2
C1512693
Non-childbearing potential
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
Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 (see below) if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
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]
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
Child-bearing potential and agrees to use one or the contraception methods listed In Section 8.1 (see below) for an approprlate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 4 months post-last dose.
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
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study.
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
A screening Holter ECG tracing that reveals clinically concerning arrhythmias.
Description

Clinically concerning arrhythmias

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2699424
UMLS CUI [1,3]
C0013801
A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
Description

Blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
Description

Heart rate

Data type

boolean

Alias
UMLS CUI [1]
C0018810
History or presence or any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
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
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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
The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology), Screening lung function tests (FEV 1) will be performed to confirm normal lung function parameters (>= 85% predicted).
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
Subjects who have suffered an upper or lower respiratory tract Infection within 4 weeks of the screening visit.
Description

Upper/lower respiratory tract Infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
Pregnant females as determined by positive serum hCG test at screening or positive urine/serum hCG test prior to dosing.
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
Lactating females
Description

Lactating females

Data type

boolean

Alias
UMLS CUI [1]
C2828358
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Description

positive Hepatitis B surface antigen, positive Hepatitis C antibody

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
A positive test for HIV antibody.
Description

Positive test for HIV antibody

Data type

boolean

Alias
UMLS CUI [1]
C0920548
The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
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
Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
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
Positive urine cotinine test at screening.
Description

Positive urine cotinine test

Data type

boolean

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C1446409
History of regular alcohol consumption within 6 months of the study.
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
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the Investigation al product (whichever is longer).
Description

Receiving an investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2348568
Exposure to more than four new chemical entities (FDA) within 12 months prior to the first dosing day.
Description

Exposure to chemical entities

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C0449788
Use of prescription or non-prescription drugs, induding vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme Inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion or the Investigator and GSK Medical Monitor the medication will not Interfere with the study procedures or compromise subject safety.
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
The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
Description

Taken of oral corticosteroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0442027
UMLS CUI [1,3]
C0149783
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
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
History of milk protein allergy
Description

Milk protein allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C3889086
Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 90 day period.
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
Unwillingness or inability to follow the procedures outlined In the protocol.
Description

No protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0525058
Subject is mentally or legally incapacitated.
Description

Mentally or legally incapacitated

Data type

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
Consumption of seville oranges, pummelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
Description

Consumption of seville oranges, pummelos, grapefruit

Data type

boolean

Alias
UMLS CUI [1]
C0330922
UMLS CUI [2]
C1006780
UMLS CUI [3]
C0995150
A known hypersensitivity to corticosteroids.
Description

Hypersensitivity to corticosteroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
Any adverse reaction including immediate or delayed hypersensitivity to any beta-2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444M lnhalation powder (e.g., lactose, magnesium stearate).
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
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Eligibility criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility criteria
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Gender, Age, informed consent
Item
Male or female between 18 and 65 years of age inclusive, at the time of Signing the informed consent.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
AST, ALT, alkaline phosphatase, bilirubin
Item
AST, ALT, alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Healthy subject (medical history, physical examination, laboratory tests, cardiac monitoring)
Item
Healthy as determined by a responsible and experienced physician, based on a medical evaluation induding medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality of laboratory parameters outside the reference range for the population being studied may be included If the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
boolean
C1708335 (UMLS CUI [1])
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])
BMI
Item
BMI within the range 18.5-29.0 kg/m2 (inclusive).
boolean
C1305855 (UMLS CUI [1])
Informed consent, protocol compliance
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Current non-smokers, pack years
Item
Subjects who are current non-smokers, who have not used any tobacco products in the 6 month period preceding the screening visit, and have a pack history of <= 10 pack years.
boolean
C0521116 (UMLS CUI [1,1])
C0337672 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
No significant abnormality on 12-1ead ECG
Item
No significant abnormality on 12-1ead ECG at screening
boolean
C1298908 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
No clinically significant abnormalities in 24 hour Holter ECG
Item
A 24 hour Holter ECG at screening that demonstrates no clinically significant abnormalities or finding that could interfere with interpretation of the study results, when assessed by an appropriately trained and experienced reviewer.
boolean
C1298908 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
FEV1
Item
FEV1 >= 85% predicted at screening
boolean
C0748133 (UMLS CUI [1])
Use of inhaler
Item
Subjects who are able to use the inhaler satisfactorily
boolean
C0085732 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
Item Group
Inclusion criteria for female
C0086287 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
Non-childbearing potential
Item
Non-childbearing potential
boolean
C1298908 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Hormone replacement therapy, menopausal status, contraception methods
Item
Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 (see below) if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
boolean
C0282402 (UMLS CUI [1])
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])
Child-bearing potential, use of contraception methods
Item
Child-bearing potential and agrees to use one or the contraception methods listed In Section 8.1 (see below) for an approprlate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 4 months post-last dose.
boolean
C3831118 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Medical interview, physical examination or screening investigations
Item
As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study.
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C1261322 (UMLS CUI [3])
C1512714 (UMLS CUI [4,1])
C0871010 (UMLS CUI [4,2])
C0008961 (UMLS CUI [4,3])
Clinically concerning arrhythmias
Item
A screening Holter ECG tracing that reveals clinically concerning arrhythmias.
boolean
C0003811 (UMLS CUI [1,1])
C2699424 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
Blood pressure
Item
A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
boolean
C0005823 (UMLS CUI [1])
Heart rate
Item
A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
boolean
C0018810 (UMLS CUI [1])
Medically significant disease, family history of QT prolongation, of early/sudden cardiac death/early cardiovascular disease.
Item
History or presence or any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
boolean
C0205476 (UMLS CUI [1,1])
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])
Current/chronic history of liver disease, hepatic or biliary abnormalities
Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
boolean
C0521116 (UMLS CUI [1,1])
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])
History of breathing problems, no normal lung function
Item
The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology), Screening lung function tests (FEV 1) will be performed to confirm normal lung function parameters (>= 85% predicted).
boolean
C0262926 (UMLS CUI [1,1])
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])
Upper/lower respiratory tract Infection
Item
Subjects who have suffered an upper or lower respiratory tract Infection within 4 weeks of the screening visit.
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Pregnant females, positive urine/serum hCG test
Item
Pregnant females as determined by positive serum hCG test at screening or positive urine/serum hCG test prior to dosing.
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Lactating females
Item
Lactating females
boolean
C2828358 (UMLS CUI [1])
positive Hepatitis B surface antigen, positive Hepatitis C antibody
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
Positive test for HIV antibody
Item
A positive test for HIV antibody.
boolean
C0920548 (UMLS CUI [1])
Taken inhaled, intranasal or topical steroids
Item
The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
boolean
C0332185 (UMLS CUI [1,1])
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])
Positive carbon monoxide (CO) or alcohol breath test
Item
Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
boolean
C0007018 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0202306 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Positive urine cotinine test
Item
Positive urine cotinine test at screening.
boolean
C1697737 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Regular alcohol consumption, unit per week
Item
History of regular alcohol consumption within 6 months of the study.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
Receiving an investigational product
Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the Investigation al product (whichever is longer).
boolean
C0332185 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Exposure to chemical entities
Item
Exposure to more than four new chemical entities (FDA) within 12 months prior to the first dosing day.
boolean
C0332157 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [2])
Use of prescription or non-prescription drugs (vitamins, herbal and dietary supplements including St Johns Wort)
Item
Use of prescription or non-prescription drugs, induding vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme Inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion or the Investigator and GSK Medical Monitor the medication will not Interfere with the study procedures or compromise subject safety.
boolean
C0332185 (UMLS CUI [1,1])
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])
Taken of oral corticosteroids
Item
The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
boolean
C0332185 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
Sensitivity of study medication, history of drug/other allergy
Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
boolean
C0020517 (UMLS CUI [1,1])
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])
Milk protein allergy
Item
History of milk protein allergy
boolean
C0262926 (UMLS CUI [1,1])
C3889086 (UMLS CUI [1,2])
Donation of blood or blood products
Item
Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 90 day period.
boolean
C0332185 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
No protocol compliance
Item
Unwillingness or inability to follow the procedures outlined In the protocol.
boolean
C1298908 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Mentally or legally incapacitated
Item
Subject is mentally or legally incapacitated.
boolean
C1306341 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Consumption of seville oranges, pummelos, grapefruit
Item
Consumption of seville oranges, pummelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
boolean
C0330922 (UMLS CUI [1])
C1006780 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
Hypersensitivity to corticosteroids
Item
A known hypersensitivity to corticosteroids.
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Hypersensitivity to beta-2 agonist/sympathomimetic drug/ inhalation powder (lactose, magnesium stearate).
Item
Any adverse reaction including immediate or delayed hypersensitivity to any beta-2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444M lnhalation powder (e.g., lactose, magnesium stearate).
boolean
C0020517 (UMLS CUI [1,1])
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])
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