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

NCT00387478 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-11-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Allergy Therapeutics

    lead INDUSTRY

Principal Investigators

  • Deepen Patel, MD, CCFP · Allied Research International Inc, Mississauga, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387478 on ClinicalTrials.gov