itn043ad grass protocol v 6 0 (27 oct 2014)...,ppxqh 7rohudqfh 1hwzrun &21),'(17,$/ 3djh...
TRANSCRIPT
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This clinical study is supported and conducted by the Immune Tolerance Network (ITN), which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
This document is confidential. It is provided for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. It is understood that the contents of this document will not be disclosed to others without written authorization from ITN and NIAID unless it is necessary to obtain informed consent from potential study participants.
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Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance
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Phleum pratense
Phleum pratense
Phleum pratense
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Phleum pratense
Phleum pratense
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Alutard SQ® Phleum Pratense ................................................................................................... 18
Grazax® ..................................................................................................................................... 18
Alutard SQ® Grass Pollen ......................................................................................................... 19
Grazax®SQ Standardized Grass Allergy Immunotherapy Tablet .............................................. 20
Intradermal and Skin Prick Tests .............................................................................................. 20
Nasal Allergen Challenge (NAC) .............................................................................................. 20
Nasal Lavage ............................................................................................................................. 21
Venepuncture ............................................................................................................................. 21
Nasal Biopsies ........................................................................................................................... 21
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Up-dosing schedule for Alutard SQ® Grass Pollen ................................................................... 33
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Immunotherapy .......................................................................................................................... 46
Intradermal and skin prick tests: ............................................................................................... 46
Nasal allergen challenge: .......................................................................................................... 47
Nasal biopsy: ............................................................................................................................. 47
Adverse Events .......................................................................................................................... 48
Serious Adverse Events .............................................................................................................. 48
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Adverse Events .......................................................................................................................... 48
Serious Adverse Events .............................................................................................................. 48
Study Medication Adverse Reactions......................................................................................... 48
Selected Study Procedures ........................................................................................................ 49
Grading and Attribution of All Other Adverse Events ............................................................... 50
Comparison of SLIT versus SCIT Treatment Arms ................................................................... 55
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Phleum pratensePhleum pratense
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Alutard SQ® Phleum Pratense
Alutard SQ Phleum pratense
Alutard SQ
Grazax®
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Alutard SQ Phleum pratense
Alutard SQ® Grass Pollen
Alutard SQ
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Alutard SQ
Grazax®SQ Standardized Grass Allergy Immunotherapy Tablet
Intradermal and Skin Prick Tests
Nasal Allergen Challenge (NAC)
Aquagen SQ, Phleum pratense,
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Nasal Lavage
Venepuncture
Nasal Biopsies
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Nasal and skin responses
Pollenseason
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ooo
all
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not
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lost to follow-up
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Phleum pratense
Phleum pratensePhleum pratense
Phleum pratense
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Phleum pratense
Phleum pratense
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Phleum pratense
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Up-dosing schedule for Alutard SQ® Grass Pollen
not
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Phleum pratense
Phleum pratense
Betula verrucosaArtemisia vulgaris Dermatophagoides
pteronyssinus Felis domesticus Canis familiarisEquus caballus Aspergillus fumigatus Cladosporium herbarum Alternaria
alternata
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in situ
P. pratense
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Phleum pratense
Phleum pratense
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: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
Guidelines for Good Clinical PracticeCommon Terminology Criteria for
Adverse Events, Version 4.0
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Immunotherapy
Intradermal and skin prick tests:
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Nasal allergen challenge:
Nasal biopsy:
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Adverse Events
Serious Adverse Events
Adverse Events
Serious Adverse Events
Study Medication Adverse Reactions
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Common Terminology Criteria for Adverse Events, Version 4.0
Selected Study Procedures
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Grading and Attribution of All Other Adverse Events
CommonTerminology Criteria for Adverse Events, Version 4.0
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oooo
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Comparison of SLIT versus SCIT Treatment Arms
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Phleum
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oror
Phleum pratense
Phleum pratense
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oror
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oror
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Phleum pratense
Phleum pratense
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before
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Note: Values are mean ± standard deviation.
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No dropout Intraclass correlation0 0.2 0.4 0.6 0.8 0.9
0.4 0.33 0.34 0.38 0.47 0.71 0.93
Standardizedtreatmenteffect
0.6 0.61 0.63 0.69 0.81 0.97 >0.990.8 0.85 0.86 0.91 0.97 >0.99 >0.99
0.95 0.94 0.95 0.98 0.99 >0.99 >0.991.0 0.97 0.97 0.98 >0.99 >0.99 >0.991.2 >0.99 >0.99 >0.99 >0.99 >0.99 >0.99
15% dropoutIntraclass correlation
0 0.2 0.4 0.6 0.8 0.90.4 0.29 0.30 0.34 0.41 0.63 0.89
Standardizedtreatmenteffect
0.6 0.55 0.56 0.62 0.74 0.93 >0.990.8 0.79 0.81 0.85 0.93 >0.99 >0.99
0.95 0.91 0.92 0.95 0.99 >0.99 >0.991.0 0.93 0.94 0.97 0.99 >0.99 >0.991.2 0.99 0.99 0.99 >0.99 >0.99 >0.99
30% dropoutIntraclass correlation
0 0.2 0.4 0.6 0.8 0.90.4 0.24 0.25 0.28 0.35 0.56 0.82
Standardizedtreatmenteffect
0.6 0.47 0.49 0.54 0.65 0.88 0.990.8 0.71 0.73 0.78 0.88 0.99 >0.99
0.95 0.85 0.86 0.90 0.96 >0.99 >0.991.0 0.88 0.89 0.92 0.97 >0.99 >0.991.2 0.97 0.97 0.98 >0.99 >0.99 >0.99
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