Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age 18 Years to 80 Years
Item
age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Informed consent
Item
Informed consent
boolean
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
WRITTEN (HL7 V3 2006_05)
288556008 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI-1)
Female infertility or Contraceptive methods
Item
Female infertility or Contraceptive methods
boolean
224526002 (SNOMED CT 2011_0131)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
76498008 (SNOMED CT 2011_0131)
14302001 (SNOMED CT 2011_0131)
10001928 (MedDRA 14.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
59261009 (SNOMED CT 2011_0131)
225370004 (SNOMED CT 2011_0131)
1305003 (SNOMED CT 2011_0131)
C0021361 (UMLS CUI-1)
C0700589 (UMLS CUI-2)
Contraceptive methods
Item
partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.
boolean
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
260676000 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
425484006 (SNOMED CT 2011_0131)
20359006 (SNOMED CT 2011_0131)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
169529008 (SNOMED CT 2011_0131)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
288556008 (SNOMED CT 2011_0131)
ENC (HL7 V3 2006_05)
242762006 (SNOMED CT 2011_0131)
385644000 (SNOMED CT 2011_0131)
224526002 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
371881003 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
19338005 (SNOMED CT 2011_0131)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
237679004 (SNOMED CT 2011_0131)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
ENC (HL7 V3 2006_05)
C0700589 (UMLS CUI-1)
Asthma severe
Item
Uncontrolled (refractory) asthma despite optimal treatment
boolean
19032002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
65897001 (SNOMED CT 2011_0131)
C0581126 (UMLS CUI-1)
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
Item
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
boolean
C0681850 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C2698651 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C2348867 (UMLS CUI 2011AA)
C0424093 (UMLS CUI 2011AA)
247756008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2348519 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0004906 (UMLS CUI 2011AA)
116575004 (SNOMED CT 2011_0131)
MTHU017342 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205166 (UMLS CUI 2011AA)
255511005 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0001644 (UMLS CUI 2011AA)
373227004 (SNOMED CT 2011_0131)
C0595726 (UMLS CUI 2011AA)
372517002 (SNOMED CT 2011_0131)
C0039771 (UMLS CUI 2011AA)
372810006 (SNOMED CT 2011_0131)
MTHU004269 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0681850 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0021461 (UMLS CUI 2011AA)
334980009 (SNOMED CT 2011_0131)
INH (HL7 V3 2006_05)
C1947911 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0082607 (UMLS CUI 2011AA)
397192001 (SNOMED CT 2011_0131)
C0073992 (UMLS CUI 2011AA)
372515005 (SNOMED CT 2011_0131)
C0965130 (UMLS CUI 2011AA)
C1130494 (UMLS CUI 2011AA)
C1121854 (UMLS CUI 2011AA)
C0054201 (UMLS CUI 2011AA)
395726003 (SNOMED CT 2011_0131)
MTHU017344 (LOINC Version 232)
C0060657 (UMLS CUI 2011AA)
414289007 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0443299 (UMLS CUI 2011AA)
263869007 (SNOMED CT 2011_0131)
C0021461 (UMLS CUI 2011AA)
334980009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0024119 (UMLS CUI 2011AA)
23426006 (SNOMED CT 2011_0131)
10025099 (MedDRA 14.1)
MTHU029811 (LOINC Version 232)
C1315011 (UMLS CUI 2011AA)
MTHU000047 (LOINC Version 232)
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
Item
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
boolean
CL414841 (UMLS CUI 2011AA)
C1879533 (UMLS CUI 2011AA)
C0085129 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10066091 (MedDRA 14.1)
C1315011 (UMLS CUI 2011AA)
MTHU000047 (LOINC Version 232)
C0681842 (UMLS CUI 2011AA)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
Item
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
boolean
C0449428 (UMLS CUI 2011AA)
272733003 (SNOMED CT 2011_0131)
C1446561 (UMLS CUI 2011AA)
C0600370 (UMLS CUI 2011AA)
372766003 (SNOMED CT 2011_0131)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0547047 (UMLS CUI 2011AA)
260370003 (SNOMED CT 2011_0131)
CL414841 (UMLS CUI 2011AA)
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
Item
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
boolean
C0439841 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0040802 (UMLS CUI 2011AA)
129018004 (SNOMED CT 2011_0131)
C0442592 (UMLS CUI 2011AA)
257585005 (SNOMED CT 2011_0131)
C2960418 (UMLS CUI 2011AA)
447113005 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
Item
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
boolean
C0008000 (UMLS CUI 2011AA)
C0200627 (UMLS CUI 2011AA)
33468001 (SNOMED CT 2011_0131)
MTHU008379 (LOINC Version 232)
C0042014 (UMLS CUI 2011AA)
27171005 (SNOMED CT 2011_0131)
10046614 (MedDRA 14.1)
MTHU000144 (LOINC Version 232)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL415192 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Body weight of <= 130 kg.
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
Item
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
boolean
C1518422 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0031809 (UMLS CUI 2011AA)
5880005 (SNOMED CT 2011_0131)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
Able to comply with the requirements of the protocol.
Item
Able to comply with the requirements of the protocol.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1709747 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Experienced a severe exacerbation within 28 days preceding Visit 1.
Item
Experienced a severe exacerbation within 28 days preceding Visit 1.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Item
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0681850 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2607914 (UMLS CUI 2011AA)
61582004 (SNOMED CT 2011_0131)
10039085 (MedDRA 14.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE 1105E)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C0014868 (UMLS CUI 2011AA)
16761005 (SNOMED CT 2011_0131)
10030216 (MedDRA 14.1)
K20.9 (ICD-10-CM Version 2010)
530.10 (ICD-9-CM Version 2011)
E10687 (CTCAE 1105E)
C2698651 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
CL031856 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
Item
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
CL025718 (UMLS CUI 2011AA)
C0025662 (UMLS CUI 2011AA)
C1518527 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
Lower respiratory tract infection within six weeks of Visit 1.5.
Item
Lower respiratory tract infection within six weeks of Visit 1.5.
boolean
C0149725 (UMLS CUI 2011AA)
50417007 (SNOMED CT 2011_0131)
10024968 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
Item
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
boolean
C0337664 (UMLS CUI 2011AA)
77176002 (SNOMED CT 2011_0131)
10048880 (MedDRA 14.1)
C0337671 (UMLS CUI 2011AA)
8517006 (SNOMED CT 2011_0131)
10015572 (MedDRA 14.1)
C1277691 (UMLS CUI 2011AA)
315609007 (SNOMED CT 2011_0131)
C0237753 (UMLS CUI 2011AA)
260299005 (SNOMED CT 2011_0131)
MTHU024869 (LOINC Version 232)
C0677453 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Blood donation (> 550 mL) in the previous two months.
Item
Blood donation (> 550 mL) in the previous two months.
boolean
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
Item
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
boolean
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0037638 (UMLS CUI 2011AA)
61010005 (SNOMED CT 2011_0131)
C1328247 (UMLS CUI 2011AA)
417928002 (SNOMED CT 2011_0131)
10000341 (MedDRA 14.1)
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
Item
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
C0006267 (UMLS CUI 2011AA)
12295008 (SNOMED CT 2011_0131)
10006445 (MedDRA 14.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
C0242379 (UMLS CUI 2011AA)
363358000 (SNOMED CT 2011_0131)
10058467 (MedDRA 14.1)
C34.90 (ICD-10-CM Version 2010)
C0036202 (UMLS CUI 2011AA)
31541009 (SNOMED CT 2011_0131)
10039486 (MedDRA 14.1)
D86.9 (ICD-10-CM Version 2010)
135 (ICD-9-CM Version 2011)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
C0034069 (UMLS CUI 2011AA)
51615001 (SNOMED CT 2011_0131)
10037383 (MedDRA 14.1)
J84.1 (ICD-10-CM Version 2010)
E13527 (CTCAE 1105E)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
Item
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0683610 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Item
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0022661 (UMLS CUI 2011AA)
90688005 (SNOMED CT 2011_0131)
10038444 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
585.6 (ICD-9-CM Version 2011)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
hypertension heart disease psoriasis or stroke
Item
hypertension heart disease psoriasis or stroke
boolean
271649006 (SNOMED CT 2011_0131)
271650006 (SNOMED CT 2011_0131)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
288556008 (SNOMED CT 2011_0131)
ENC (HL7 V3 2006_05)
36692007 (SNOMED CT 2011_0131)
432119003 (SNOMED CT 2011_0131)
10002329 (MedDRA 14.1)
I72.9 (ICD-10-CM Version 2010)
442.9 (ICD-9-CM Version 2011)
C0020538 (UMLS CUI-1)
C0018799 (UMLS CUI-2)
C0033860 (UMLS CUI-3)
C0038454 (UMLS CUI-4)
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Item
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2607914 (UMLS CUI 2011AA)
61582004 (SNOMED CT 2011_0131)
10039085 (MedDRA 14.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE 1105E)
C0018621 (UMLS CUI 2011AA)
367498001 (SNOMED CT 2011_0131)
10048908 (MedDRA 14.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
C0014868 (UMLS CUI 2011AA)
16761005 (SNOMED CT 2011_0131)
10030216 (MedDRA 14.1)
K20.9 (ICD-10-CM Version 2010)
530.10 (ICD-9-CM Version 2011)
E10687 (CTCAE 1105E)
C2698651 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
CL031856 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
Item
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
C0220825 (UMLS CUI 2011AA)
C0036043 (UMLS CUI 2011AA)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
C1882330 (UMLS CUI 2011AA)
C0030735 (UMLS CUI 2011AA)
10034192 (MedDRA 14.1)
The subject's primary care physician recommends the subject should not take part in the study.
Item
The subject's primary care physician recommends the subject should not take part in the study.
boolean
C0033131, C0017319 (UMLS CUI 2011AA)
446050000, 59058001 (SNOMED CT 2011_0131)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Item
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
C0805586 (UMLS CUI 2011AA)
MTHU005364 (LOINC Version 232)
C1254351 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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