Diagnosis of cystic fibrosis (sweat chloride level, genotype, clinical features)
Item
Diagnosis of CF based on the following: sweat chloride > 60 mE /L and/or genotype with 2 identifiable mutations consistent with CFt; (DeltaF508 homozygote, or DeltaF508 heterozygote with a second allele known to cause the disease or two alleles known to cause a class I, II, or III mutation) and one or more clinical features consistent with CF.
boolean
C0010674 (UMLS CUI [1,1])
C1304760 (UMLS CUI [1,2])
C0010674 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C0010674 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C0205210 (UMLS CUI [3,3])
Gender, Age
Item
Male and female subjects aged >= 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-childbearing potential/ Use of contraceptive precautions
Item
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females 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 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory). Child-bearing potential and agrees to use one of the contraception methods for an appropriate 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 one week after the last dose.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Non-smokers/ former smoker, chewing tobacco products
Item
Patients are non-smokers or former smokers by history. Subjects who only use chewing tobacco products may be enrolled at the discretion of the Investigator and after consultation with the GSK medical monitor.
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C0241410 (UMLS CUI [3,1])
C0008961 (UMLS CUI [3,2])
C0022423 (UMLS CUI [3,3])
C0009818 (UMLS CUI [3,4])
C1708968 (UMLS CUI [3,5])
Stable medical status, no hospital admission, no systemic antibiotic therapy
Item
In the judgement of the investigator the patient is clinically stable with no change in symptoms or medication, no admissions to hospital, and no intravenous antibiotic therapy for at least 1 month prior to dosing.
boolean
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C1298908 (UMLS CUI [2,1])
C0184666 (UMLS CUI [2,2])
C1298908 (UMLS CUI [3,1])
C0348016 (UMLS CUI [3,2])
C0338237 (UMLS CUI [3,3])
Lung function tests
Item
Able to perform lung function tests reliably.
boolean
C0085732 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
FEV1
Item
FEV1 > 40% and < 110% predicted.
boolean
C0748133 (UMLS CUI [1])
No periods of exacerbation
Item
Excluding periods of exacerbation, FEV1 has not decreased by > 15% over the past 12 months
boolean
C1298908 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
Bacterial organism typical for CF
Item
Clinically colonized by a bacterial organism commonly seen in cystic fibrosis other than Burkholderia cepacia (i.e. Pseudomonas spp., Staphylococcus aureus, Stenotrophomonas, B. Gladioli) as evidenced by identification in sputum culture within the past year. To be eligible a CF patient must have colonization of at least one typical CF organism.
boolean
C0038056 (UMLS CUI [1,1])
C0029235 (UMLS CUI [1,2])
C3538928 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,4])
C0033808 (UMLS CUI [2])
C0038172 (UMLS CUI [3])
C0445842 (UMLS CUI [4])
C0318038 (UMLS CUI [5])
Negative pregnancy test, no nursing
Item
To be eligible, female patients must have a negative pregnancy test (urine or serum) and not be nursing at screening or prior to dosing.
boolean
C0427780 (UMLS CUI [1])
C1298908 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
QTcB or QTcF
Item
Subjects must have a QTcB or QTcF < 450 msec at screening as determined by the investigators review.
boolean
C1882512 (UMLS CUI [1])
C1882513 (UMLS CUI [2])
AST, ALT, ALK, Bilirubin
Item
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within twice (2x) the upper limit of normal at screening and bilirubin within 1.25x ULN at screening. AST, ALT, alkaline phosphatase and bilirubin <= 2.0x ULN (isolated bilirubin 2.0xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Contraception method for male
Item
Male subjects must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until one wee after the last dose.
boolean
C0700589 (UMLS CUI [1,1])
C1706180 (UMLS CUI [1,2])
Informed consent
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])
Ability to comply study requirements
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
boolean
C0085732 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Clinically relevant abnormality (medical assessment, laboratory, ECG), Neutrophil count
Item
Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG, that is not associated with cystic fibrosis. - Neutrophil count <1.5x109/L
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0260877 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2985739 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
C0200633 (UMLS CUI [4])
Clinically unstable pancreatic function
Item
In the judgment of the PI, the patient: suffers from clinically unstable pancreatic function
boolean
C0022423 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0030274 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
Clinically significant weight loss
Item
In the judgment of the PI, the patient: has clinically significant weight loss (>= 5% after a previously stable period).
boolean
C0022423 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,4])
C1262477 (UMLS CUI [1,5])
Uncontrolled hyperglycemia or recent hypoglycemia
Item
In the judgment of the PI, the patient: has evidence of uncontrolled hyperglycemia or recent hypoglycemia
boolean
C0022423 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0020456 (UMLS CUI [1,4])
C0022423 (UMLS CUI [2,1])
C1521895 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0020615 (UMLS CUI [2,4])
Change in pancreatic enzyme
Item
In the judgment of the PI, the patient: has recent change in pancreatic enzyme requirements in the past 2 months.
boolean
C0022423 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0030274 (UMLS CUI [1,5])
C0014442 (UMLS CUI [1,6])
Recent viral infection, steroid/ antibiotic treatment
Item
Recent viral infection (within 4 weeks of dosing), with or without steroid or antibiotic treatment. Presumed viral infection will be determined according to the judgment of the Investigator and no specific testing for virus will be required.
boolean
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0042769 (UMLS CUI [1,4])
Sputum sample
Item
Subjects unable to produce a technically acceptable sputum sample.
boolean
C0038056 (UMLS CUI [1,1])
C0681875 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Cirrhose
Item
Clinically significant hepatic impairment: Evidence of cirrhosis.
boolean
C2826293 (UMLS CUI [1,1])
C0948807 (UMLS CUI [1,2])
C1623038 (UMLS CUI [2])
Elevated INR, Vitamin K deficiency
Item
Clinically significant hepatic impairment: Patients with elevated INR that is due to suspected vitamin K deficiency may be enrolled at the discretion of the Investigator and after consultation with the GSK medical monitor.
boolean
C2826293 (UMLS CUI [1,1])
C0948807 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C0009818 (UMLS CUI [2,3])
C1708968 (UMLS CUI [2,4])
C0042880 (UMLS CUI [2,5])
C0332282 (UMLS CUI [2,6])
C0525032 (UMLS CUI [2,7])
C0205217 (UMLS CUI [2,8])
Blood pressure
Item
Blood pressure persistently > 155/95 mmHg at screening.
boolean
C0005823 (UMLS CUI [1])
Positive HIV, Hepatitis B surface antigen, Hepatitis C antibody
Item
Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening.
boolean
C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
Regular alcohol consumption
Item
History of regular alcohol consumption averaging 7 drinks/week for women or 14 drinks/week for men.
boolean
C0262926 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
Urinary cotinine levels indicative of smoking
Item
Urinary cotinine levels indicative of smoking.
boolean
C0202363 (UMLS CUI [1,1])
C1519386 (UMLS CUI [1,2])
Oral or parenteral corticosteroids, regular NSAIDs use
Item
Use of oral or parenteral corticosteroids within 4 weeks of screening; regular use ( > 3 x/wk) of high dose NSAIDS (e.g. > 1.6g ibuprofen/day on a regular basis), within 4 weeks of screening.
boolean
C4053960 (UMLS CUI [1])
C0205272 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
Colonization with Burkholderia cepacia
Item
Colonization with Burkholderia cepacia
boolean
C4289767 (UMLS CUI [1,1])
C0085469 (UMLS CUI [1,2])
Mycobacterial infection treatment
Item
Subjects currently being treated for mycobacterial infection.
boolean
C0332185 (UMLS CUI [1,1])
C0026918 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Allergic Bronchopulmonary Aspergillosis
Item
Subjects with presumed active Allergic Bronchopulmonary Aspergillosis (ABPA)
boolean
C0004031 (UMLS CUI [1])
Therapy with azithromycin
Item
Subjects who have newly started therapy with azithromycin within the past 3 months.
boolean
C0332185 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0052796 (UMLS CUI [1,3])
C0039798 (UMLS CUI [1,4])
Clinically significant hemoptysis
Item
In the judgment of the investigator, clinically significant hemoptysis ( > 30 cc per episode) within the last 6 months.
boolean
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0019079 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Recent donation of blood
Item
Donation of blood in excess of 500 mL within a 56-day period prior to dosing
boolean
C0042769 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
Participation in trials with medication/ new chemical entity
Item
Participation in a trial with any drug within 30 days or 5 half-lives (whichever is longer), or participation in a trial with a new chemical entity within 2 months prior to first dose of current study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
boolean
C2348568 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1298908 (UMLS CUI [3,3])
C0392760 (UMLS CUI [3,4])
C0008976 (UMLS CUI [3,5])
C0184661 (UMLS CUI [3,6])
Positive pre-study drug/ alcohol screen (benzodiazepines and other anxiolytics are allowed)
Item
The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, and cannabinoids. Subjects who use benzodiazepines or other anxiolytic on a regular basis can be included at the discretion of the investigator and in consultation with the GSK medical monitor.
boolean
C0743295 (UMLS CUI [1])
C1446409 (UMLS CUI [2,1])
C0420032 (UMLS CUI [2,2])
C0005064 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0008961 (UMLS CUI [3,3])
C0022423 (UMLS CUI [3,4])
C3826021 (UMLS CUI [3,5])
C0040616 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0008961 (UMLS CUI [4,3])
C0022423 (UMLS CUI [4,4])
C3826021 (UMLS CUI [4,5])
Inhaled antibiotic during study
Item
Patients may not be on an inhaled antibiotic during the study (i.e. must be an 'off- TOBI' month; cessation of TOBI or other inhaled antibiotics commences from one week prior to dosing until final PK draw). Patients on maintenance therapy with hypertonic saline solution or inhaled DNase may continue these therapies.
boolean
C0338237 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Unwillingness/ inability to comply study requirements
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
text
C1299582 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0558080 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])