drugset / Trial / NCT00387478

Investigation of Efficacy and Safety of Tree MATAMPL,Tree MATA, and Placebo in Patients With Birch-Induced Seasonal Allergic Rhinitis

NCT00387478 ↗

Phase 2 Terminated 121 enrolled Allergy Therapeutics
RandomizedParallel-groupDouble-blindTreatment

Summary

Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season. In this Study the Efficacy will be assessed by exposing allergic subjects to birch pollen in an environmental exposure chamber EEC. Patient symptomatic response to birch pollen and patient quality of life in the EEC will be determined.

Timeline

Start
2006-10
Primary completion
2007-07
Completion
2007-07

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollement target could not be achieved, study will not resume”

Drugs

EvaluationDrugModalityDoseRoute
Subject Tree MATA MPL Other / unclassified 4000 unknown Other
Subject TreeMATA Vaccine 4000 unknown Other