ID

39805

Descripción

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the eligibility criteria. It has to be filled in for screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Palabras clave

Versiones (2)
  1. 17/02/20 17/02/20 -
  2. 21/02/20 21/02/20 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 febbraio 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

Inglés

Eligibility criteria

1 formularios  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Eligibility check
Descripción

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Descripción

If you tick no, please select all boxes corresponding to violations of any inclusion/exclusion criteria.

Tipo de datos

text

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Descripción

Inclusion criteria

Alias
UMLS CUI-1
C1512693
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.
Descripción

Diagnosis of cystic fibrosis (sweat chloride level, genotype, clinical features)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010674
UMLS CUI [1,2]
C1304760
UMLS CUI [2,1]
C0010674
UMLS CUI [2,2]
C0017431
UMLS CUI [3,1]
C0010674
UMLS CUI [3,2]
C2348519
UMLS CUI [3,3]
C0205210
Male and female subjects aged >= 18 years of age
Descripción

Gender, Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
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.
Descripción

Contraception methods: 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% effectiveness criteria 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]
C0700589
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.
Descripción

Former smokers will be defined as those who have not smoked for >=6 months.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0337671
UMLS CUI [3,1]
C0241410
UMLS CUI [3,2]
C0008961
UMLS CUI [3,3]
C0022423
UMLS CUI [3,4]
C0009818
UMLS CUI [3,5]
C1708968
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.
Descripción

Stable medical status, no hospital admission, no systemic antibiotic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0205476
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0184666
UMLS CUI [3,1]
C1298908
UMLS CUI [3,2]
C0348016
UMLS CUI [3,3]
C0338237
Able to perform lung function tests reliably.
Descripción

Lung function tests

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0024119
FEV1 > 40% and < 110% predicted.
Descripción

FEV1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748133
Excluding periods of exacerbation, FEV1 has not decreased by > 15% over the past 12 months
Descripción

No periods of exacerbation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C4086268
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.
Descripción

Bacterial organism typical for CF

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C0029235
UMLS CUI [1,3]
C3538928
UMLS CUI [1,4]
C0010674
UMLS CUI [2]
C0033808
UMLS CUI [3]
C0038172
UMLS CUI [4]
C0445842
UMLS CUI [5]
C0318038
To be eligible, female patients must have a negative pregnancy test (urine or serum) and not be nursing at screening or prior to dosing.
Descripción

Negative pregnancy test, no nursing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0006147
Subjects must have a QTcB or QTcF < 450 msec at screening as determined by the investigators review.
Descripción

QTcB or QTcF

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1882512
UMLS CUI [2]
C1882513
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%).
Descripción

AST, ALT, ALK, Bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201913
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.
Descripción

Contraception methods: Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Condom (during non-vaginal intercourse with any partner - male or female) OR Condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) (during sexual intercourse with a female). For those male subjects with confirmed infertility, an occlusive cap is not required.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1706180
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Descripción

Ability to comply study requirements

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C2348563
Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI-1
C0680251
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
Descripción

Clinically relevant abnormality (medical assessment, laboratory, ECG), Neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0582103
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0260877
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2985739
UMLS CUI [3,3]
C1623258
UMLS CUI [4]
C0200633
In the judgment of the PI, the patient: suffers from clinically unstable pancreatic function
Descripción

PI judgment: Clinically unstable pancreatic function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C0030274
UMLS CUI [1,4]
C0443343
UMLS CUI [1,5]
C0205210
In the judgment of the PI, the patient: has clinically significant weight loss (>= 5% after a previously stable period).
Descripción

PI judgment: Clinically significant weight loss

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0750502
UMLS CUI [1,5]
C1262477
In the judgment of the PI, the patient: has evidence of uncontrolled hyperglycemia or recent hypoglycemia
Descripción

PI judgment: Uncontrolled hyperglycemia or recent hypoglycemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0020456
UMLS CUI [2,1]
C0022423
UMLS CUI [2,2]
C1521895
UMLS CUI [2,3]
C0332185
UMLS CUI [2,4]
C0020615
In the judgment of the PI, the patient: has recent change in pancreatic enzyme requirements in the past 2 months.
Descripción

PI judgment: Change in pancreatic enzyme

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C0332185
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0030274
UMLS CUI [1,6]
C0014442
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.
Descripción

PI judgment: Recent viral infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0332185
UMLS CUI [1,4]
C0042769
Subjects unable to produce a technically acceptable sputum sample.
Descripción

Sputum sample

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038056
UMLS CUI [1,2]
C0681875
UMLS CUI [1,3]
C1299582
Clinically significant hepatic impairment: Evidence of cirrhosis.
Descripción

Hepatic Impairment: Cirrhose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0948807
UMLS CUI [2]
C1623038
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.
Descripción

Hepatic Impairment: Elevated INR, Vitamin K deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0948807
UMLS CUI [2,1]
C0008961
UMLS CUI [2,2]
C0022423
UMLS CUI [2,3]
C0009818
UMLS CUI [2,4]
C1708968
UMLS CUI [2,5]
C0042880
UMLS CUI [2,6]
C0332282
UMLS CUI [2,7]
C0525032
UMLS CUI [2,8]
C0205217
Blood pressure persistently > 155/95 mmHg at screening.
Descripción

Blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005823
Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening.
Descripción

Positive HIV, Hepatitis B surface antigen, Hepatitis C antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
History of regular alcohol consumption averaging 7 drinks/week for women or 14 drinks/week for men.
Descripción

One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits) within 6 months of screening.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0001948
Urinary cotinine levels indicative of smoking.
Descripción

Urinary cotinine levels indicative of smoking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C1519386
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.
Descripción

Oral or parenteral corticosteroids, regular NSAIDs use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4053960
UMLS CUI [2,1]
C0205272
UMLS CUI [2,2]
C0003211
Colonization with Burkholderia cepacia
Descripción

Colonization with Burkholderia cepacia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4289767
UMLS CUI [1,2]
C0085469
Subjects currently being treated for mycobacterial infection.
Descripción

Mycobacterial infection treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0026918
UMLS CUI [1,3]
C0087111
Subjects with presumed active Allergic Bronchopulmonary Aspergillosis (ABPA)
Descripción

Allergic Bronchopulmonary Aspergillosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004031
Subjects who have newly started therapy with azithromycin within the past 3 months.
Descripción

Therapy with azithromycin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0052796
UMLS CUI [1,4]
C0039798
In the judgment of the investigator, clinically significant hemoptysis ( > 30 cc per episode) within the last 6 months.
Descripción

Clinically significant hemoptysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0019079
UMLS CUI [1,4]
C2826293
Donation of blood in excess of 500 mL within a 56-day period prior to dosing
Descripción

Recent donation of blood

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042769
UMLS CUI [1,2]
C0005794
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.
Descripción

Participation in trials with medication/ new chemical entity, except if not affecting clinical trial procedures or patient safety

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1298908
UMLS CUI [3,4]
C0392760
UMLS CUI [3,5]
C0008976
UMLS CUI [3,6]
C0184661
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C1298908
UMLS CUI [4,4]
C0392760
UMLS CUI [4,5]
C1113679
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.
Descripción

Positive pre-study drug/ alcohol screen (benzodiazepines and other anxiolytics are allowed)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2,1]
C1446409
UMLS CUI [2,2]
C0420032
UMLS CUI [3,1]
C0005064
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C0008961
UMLS CUI [3,4]
C0022423
UMLS CUI [3,5]
C3826021
UMLS CUI [4,1]
C0040616
UMLS CUI [4,2]
C0683607
UMLS CUI [4,3]
C0008961
UMLS CUI [4,4]
C0022423
UMLS CUI [4,5]
C3826021
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.
Descripción

Inhaled antibiotic during study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0338237
UMLS CUI [1,2]
C0001559
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
Unwillingness or inability to follow the procedures outlined in the protocol.
Descripción

Unwillingness/ inability to comply study requirements

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C2348563
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Similar models

Eligibility criteria

1 formularios
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility check
C0013893 (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)
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])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
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])
PI judgment: 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])
PI judgment: 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])
PI judgment: 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])
PI judgment: 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])
PI judgment: Recent viral infection
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])
Hepatic Impairment: Cirrhose
Item
Clinically significant hepatic impairment: Evidence of cirrhosis.
boolean
C2826293 (UMLS CUI [1,1])
C0948807 (UMLS CUI [1,2])
C1623038 (UMLS CUI [2])
Hepatic Impairment: 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, except if not affecting clinical trial procedures or patient safety
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])
C0332300 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C1298908 (UMLS CUI [4,3])
C0392760 (UMLS CUI [4,4])
C1113679 (UMLS CUI [4,5])
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])
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