ID
43074
Description
ODM derived from http://clinicaltrials.gov/show/NCT00640016
Link
http://clinicaltrials.gov/show/NCT00640016
Keywords
Versions (4)
- 12/9/13 12/9/13 - Martin Dugas
- 8/8/14 8/8/14 - Martin Dugas
- 5/22/15 5/22/15 - Martin Dugas
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
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
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- C0680251
Description
Experienced a severe exacerbation within 28 days preceding Visit 1.
Data type
boolean
Alias
- UMLS CUI 2015AA
- C0038218
- UMLS CUI 2015AA-2
- C3828653
Description
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.
Data type
boolean
Alias
- UMLS CUI 2015AA
- C0018621
- UMLS CUI 2015AA-2
- C1821205
- UMLS CUI 2015AA-3
- C3828653
Description
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.
Data type
boolean
Alias
- UMLS CUI 2015AA
- C2348568
Description
Lower respiratory tract infection within six weeks of Visit 1.5.
Data type
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
- C1512346
- HL7 V3 2006_05-2
- ENC
Description
Current smokers or ex-smokers with more than 10 pack-years
Data type
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
Description
Blood donation (> 550 mL) in the previous two months.
Data type
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
Description
substance use
Data type
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
Description
other significant lung disease
Data type
boolean
Alias
- UMLS CUI-1
- C0024115
- UMLS CUI-2
- C0750502
Description
prohibited medications
Data type
boolean
Alias
- SNOMED CT 2011_0131
- 68405009
- HL7 V3 2006_05
- ENC
- LOINC Version 232
- MTHU024501
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3242263
Description
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Data type
boolean
Alias
- UMLS CUI 2015AA
- C0184774
Description
hypertension heart disease psoriasis or stroke
Data type
boolean
Alias
- UMLS CUI-1
- C0020538
- UMLS CUI-2
- C0033860
- UMLS CUI-3
- C0038454
Description
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).
Data type
boolean
Alias
- UMLS CUI 2015AA
- C3844688
Description
GP does not recommend participation
Data type
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
Description
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Data type
boolean
Alias
- UMLS CUI 2015AA
- C0020517
- UMLS CUI 2015AA-2
- C0013227
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C0039771 (UMLS CUI-5)
C0595726 (UMLS CUI-6)
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C0205195 (UMLS CUI-8)
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C0337671 (UMLS CUI-2)
C1277691 (UMLS CUI-3)
25179006 (SNOMED CT 2011_0131)
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C0038454 (UMLS CUI-3)
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