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Cholecalciferol

Phase 2

Allergic Rhinoconjunctivitis | Small molecule | Respiratory |Pulmonx Corporation|Last Updated: Jun 25, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Cholecalciferol · 1 trial · 1 indication

Phase 2 1
NCT01466465Vitamin D and Grass Pollen Specific ImmunotherapyAllergic Rhinoconjunctivitis
COMPLETED35 Analytics
PHASE2COMPLETED
Vitamin D and Grass Pollen Specific Immunotherapy
Allergic Rhinoconjunctivitis
NCT0146646535
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Study Endpoints

Primary Endpoints

wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
three years
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VigantolEXPERIMENTAL -
neutral oil (vigantol carrier)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CholecalciferolDRUGgiven orally, once daily, before grass pollen season
middle-chain fatty acids (carrier)OTHERgiven orally, once daily, before grass pollen season
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * written informed consent * relative Vitamin D deficiency * clinical relevant grass pollen allergy * positive intradermal test with grass pollen * forced expiratory volume at one second (FEV1) \> 70% Exclusion Criteria: * current specific immunotherapy * instable allergic ast...

Countries:Germany
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