ID
10248
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00640016
Länk
http://clinicaltrials.gov/show/NCT00640016
Nyckelord
Versioner (4)
- 2013-12-09 2013-12-09 - Martin Dugas
- 2014-08-08 2014-08-08 - Martin Dugas
- 2015-05-22 2015-05-22 - Martin Dugas
- 2021-09-20 2021-09-20 -
Uppladdad den
22 maj 2015
DOI
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Licens
Creative Commons BY 4.0
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A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354
Eligibility
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- C0680251
Beskrivning
Experienced a severe exacerbation within 28 days preceding Visit 1.
Datatyp
boolean
Alias
- UMLS CUI 2015AA
- C0038218
- UMLS CUI 2015AA-2
- C3828653
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI 2015AA
- C0018621
- UMLS CUI 2015AA-2
- C1821205
- UMLS CUI 2015AA-3
- C3828653
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI 2015AA
- C2348568
Beskrivning
Lower respiratory tract infection within six weeks of Visit 1.5.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0149725
- SNOMED CT 2011_0131
- 50417007
- MedDRA 14.1
- 10024968
- UMLS CUI 2011AA-2
- C0439230
- SNOMED CT 2011_0131-2
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA-3
- C1554196
- HL7 V3 2006_05-2
- ENC
Beskrivning
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).
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 77176002
- MedDRA 14.1
- 10048880
- SNOMED CT 2011_0131-2
- 8517006
- MedDRA 14.1-2
- 10015572
- SNOMED CT 2011_0131-3
- 315609007
- SNOMED CT 2011_0131-4
- 260299005
- LOINC Version 232
- MTHU024869
- SNOMED CT 2011_0131-5
- 258703001
- HL7 V3 2006_05
- D
- SNOMED CT 2011_0131-6
- 258707000
- HL7 V3 2006_05-2
- Y
- UMLS CUI-1
- C0337664
- UMLS CUI-2
- C0337671
- UMLS CUI-3
- C1277691
Beskrivning
Blood donation (> 550 mL) in the previous two months.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0005794
- SNOMED CT 2011_0131
- 25179006
- UMLS CUI 2011AA-2
- C0205156
- SNOMED CT 2011_0131-2
- 9130008
- UMLS CUI 2011AA-3
- C0205448
- SNOMED CT 2011_0131-3
- 19338005
- UMLS CUI 2011AA-4
- C0439231
- SNOMED CT 2011_0131-4
- 258706009
- HL7 V3 2006_05
- MO
Beskrivning
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 160592001
- SNOMED CT 2011_0131-2
- 61254005
- SNOMED CT 2011_0131-3
- 18669006
- SNOMED CT 2011_0131-4
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
- SNOMED CT 2011_0131-5
- 61010005
- SNOMED CT 2011_0131-6
- 417928002
- MedDRA 14.1-2
- 10000341
- UMLS CUI-1
- C1705534
- UMLS CUI-2
- C0001948
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI-1
- C0024115
- UMLS CUI-2
- C0750502
Beskrivning
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 68405009
- HL7 V3 2006_05
- ENC
- LOINC Version 232
- MTHU024501
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3242263
Beskrivning
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Datatyp
boolean
Alias
- UMLS CUI 2015AA
- C0184774
Beskrivning
systolic blood pressure > 200 mmHg, or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm.
Datatyp
boolean
Alias
- UMLS CUI-1
- C0020538
- UMLS CUI-2
- C0033860
- UMLS CUI-3
- C0038454
Beskrivning
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).
Datatyp
boolean
Alias
- UMLS CUI 2015AA
- C3844688
Beskrivning
The subject's primary care physician recommends the subject should not take part in the study.
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 446050000, 59058001
- LOINC Version 232
- MTHU036724
- HL7 V3 2006_05
- RMD
- SNOMED CT 2011_0131-2
- 116154003
- HL7 V3 2006_05-2
- PART
- SNOMED CT 2011_0131-3
- 110465008
- UMLS CUI-1
- C0017319
- UMLS CUI-2
- C3242266
Beskrivning
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Datatyp
boolean
Alias
- UMLS CUI 2015AA
- C0020517
- UMLS CUI 2015AA-2
- C0013227
Similar models
Eligibility
- StudyEvent: Eligibility
C0001779 (UMLS CUI-1)
MTHU021546 (LOINC Version 232)
WRITTEN (HL7 V3 2006_05)
288556008 (SNOMED CT 2011_0131-2)
C0021430 (UMLS CUI-1)
8619003 (SNOMED CT 2011_0131-2)
10021926 (MedDRA 14.1)
236886002 (SNOMED CT 2011_0131-3)
10021151 (MedDRA 14.1-2)
76498008 (SNOMED CT 2011_0131-4)
14302001 (SNOMED CT 2011_0131-5)
10001928 (MedDRA 14.1-3)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
258707000 (SNOMED CT 2011_0131-6)
Y (HL7 V3 2006_05)
146680009 (SNOMED CT 2011_0131-7)
10010808 (MedDRA 14.1-4)
59261009 (SNOMED CT 2011_0131-8)
225370004 (SNOMED CT 2011_0131-9)
1305003 (SNOMED CT 2011_0131-10)
C0021361 (UMLS CUI-1)
C0700589 (UMLS CUI-2)
SIGOTHR (HL7 V3 2006_05)
260676000 (SNOMED CT 2011_0131-2)
260676000 (SNOMED CT 2011_0131-3)
425484006 (SNOMED CT 2011_0131-4)
20359006 (SNOMED CT 2011_0131-5)
268460000 (SNOMED CT 2011_0131-6)
10022745 (MedDRA 14.1)
169529008 (SNOMED CT 2011_0131-7)
258706009 (SNOMED CT 2011_0131-8)
MO (HL7 V3 2006_05-2)
288556008 (SNOMED CT 2011_0131-9)
ENC (HL7 V3 2006_05-3)
242762006 (SNOMED CT 2011_0131-10)
385644000 (SNOMED CT 2011_0131-11)
224526002 (SNOMED CT 2011_0131-12)
146680009 (SNOMED CT 2011_0131-13)
10010808 (MedDRA 14.1-2)
371881003 (SNOMED CT 2011_0131-14)
110465008 (SNOMED CT 2011_0131-15)
19338005 (SNOMED CT 2011_0131-16)
258706009 (SNOMED CT 2011_0131-17)
MO (HL7 V3 2006_05-4)
237679004 (SNOMED CT 2011_0131-18)
250425007 (SNOMED CT 2011_0131-19)
10036574 (MedDRA 14.1-3)
ENC (HL7 V3 2006_05-5)
C0700589 (UMLS CUI-1)
20646008 (SNOMED CT 2011_0131-2)
195967001 (SNOMED CT 2011_0131-3)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131-4)
MTHU008876 (LOINC Version 232-2)
65897001 (SNOMED CT 2011_0131-5)
C0581126 (UMLS CUI-1)
C0004906 (UMLS CUI-2)
C3248292 (UMLS CUI-3)
C0001644 (UMLS CUI-4)
C0039771 (UMLS CUI-5)
C0595726 (UMLS CUI-6)
C0205360 (UMLS CUI-7)
C0205195 (UMLS CUI-8)
C2733011 (UMLS CUI-2)
C0439841 (UMLS CUI 2015AA-2)
C0522054 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA-2)
405078008 (SNOMED CT 2011_0131-2)
C1709747 (UMLS CUI 2011AA-3)
C3828653 (UMLS CUI 2015AA-2)
C1821205 (UMLS CUI 2015AA-2)
C3828653 (UMLS CUI 2015AA-3)
50417007 (SNOMED CT 2011_0131)
10024968 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA-2)
258705008 (SNOMED CT 2011_0131-2)
WK (HL7 V3 2006_05)
C1554196 (UMLS CUI 2011AA-3)
ENC (HL7 V3 2006_05-2)
10048880 (MedDRA 14.1)
8517006 (SNOMED CT 2011_0131-2)
10015572 (MedDRA 14.1-2)
315609007 (SNOMED CT 2011_0131-3)
260299005 (SNOMED CT 2011_0131-4)
MTHU024869 (LOINC Version 232)
258703001 (SNOMED CT 2011_0131-5)
D (HL7 V3 2006_05)
258707000 (SNOMED CT 2011_0131-6)
Y (HL7 V3 2006_05-2)
C0337664 (UMLS CUI-1)
C0337671 (UMLS CUI-2)
C1277691 (UMLS CUI-3)
25179006 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA-2)
9130008 (SNOMED CT 2011_0131-2)
C0205448 (UMLS CUI 2011AA-3)
19338005 (SNOMED CT 2011_0131-3)
C0439231 (UMLS CUI 2011AA-4)
258706009 (SNOMED CT 2011_0131-4)
MO (HL7 V3 2006_05)
61254005 (SNOMED CT 2011_0131-2)
18669006 (SNOMED CT 2011_0131-3)
26416006 (SNOMED CT 2011_0131-4)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
61010005 (SNOMED CT 2011_0131-5)
417928002 (SNOMED CT 2011_0131-6)
10000341 (MedDRA 14.1-2)
C1705534 (UMLS CUI-1)
C0001948 (UMLS CUI-2)
C0750502 (UMLS CUI-2)
ENC (HL7 V3 2006_05)
MTHU024501 (LOINC Version 232)
C0013227 (UMLS CUI-1)
C3242263 (UMLS CUI-2)
C0033860 (UMLS CUI-2)
C0038454 (UMLS CUI-3)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
116154003 (SNOMED CT 2011_0131-2)
PART (HL7 V3 2006_05-2)
110465008 (SNOMED CT 2011_0131-3)
C0017319 (UMLS CUI-1)
C3242266 (UMLS CUI-2)
C0013227 (UMLS CUI 2015AA-2)