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Sponsored by: |
Allergy Therapeutics |
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Information provided by: | Allergy Therapeutics |
ClinicalTrials.gov Identifier: | NCT00110786 |
Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed 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 safety and efficacy of Ragweed MATAMPL will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber (EEC). Patient symptomatic response to pollen and patient quality of life in the EEC will be determined.
Condition | Intervention | Phase |
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Type I Hypersensitivity |
Biological: Ragweed MATAMPL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind Study to Investigate the Clinical Efficacy and Safety of Ragweed MATAMPL (Allergy Therapeutics®), Pollinex®-R (Allergy Therapeutics®) and Placebo in Patients With Seasonal Allergic Rhinitis With Ragweed Allergy, in an Environmental Exposure Chamber (EEC) Model, With Follow-Up During a Natural Ragweed Pollen Season |
Estimated Enrollment: | 240 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Allied Research International Inc. | |
Mississauga, Ontario, Canada, L4W 1N2 |
Principal Investigator: | Deepen Patel, MD | Allied Research International Inc. |
Study ID Numbers: | RagweedMATAMPL204, P2DP05001 |
Study First Received: | May 13, 2005 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00110786 |
Health Authority: | Canada: Health Canada |
Allergy Specific Immunotherapy Ragweed Environmental Exposure Chamber |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Diseases Rhinitis, Allergic, Seasonal |
Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Immune System Diseases Nose Diseases |