NCT00387478

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

A Double Blind Study to Investigate the Clinical Efficacy and Safety of TreeMATAMPL (Allergy Therapeutics, (UK) Ltd.), TreeMATA (Allergy Therapeutics, (UK) Ltd.) and Placebo in Patients With Seasonal Allergic Rhinitis Due to Birch Pollen Allergy, in an Environmental Exposure Chamber (EEC) Model When Exposed to Birch Pollen and Oak Pollen

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Allergy Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type I Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	Tree MATA MPL or Tree MATA	4 injections of increasing dose strength for Tree MATA MPL or Tree MATA: 1. 600 SU/0.5 ml 2. 1600 SU/0.5 ml 3. 4000 SU/0.5 ml 4. 4000 SU/0.6 ml 4 injections of 0.5 mL of 2% w/v L-tyrosine for Placebo

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-10-13
• Last updated: 2020-11-30

Locations

1 site across 1 country: Canada