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])
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])
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])