Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma Clinical Trial
Official title:
Randomized, DB, Parallel Group, MC Study to Evaluate the Efficacy and Safety of Four Doses of Depigmented Glutaraldehyde Polymerized Birch Pollen Allergenic Extract (Depigoid Birch) in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the
correct dose.
4 concentrations of a birch pollen allergen extract are applied in this study. Duration of
therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e.
comparison between treatment arms of increased amount of quantities of allergen to provoke a
positive CPT at the end of treatment.
This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly
intervals 5x injections of 0,5 ml of a solution of modified birch pollen extract outside the
pollen season. The primary endpoint therefore is not the therapeutic effect of the specific
immunotherapy (effect on symptoms of allergy during the birch pollen season) but the effect
on the CPT. Acc. to the EMEA "Guideline on clinical development of products for specific
immunotherapy for the treatment of allergic diseases" provocation tests are accepted as
primary outcomes for dose-finding studies.
For the CPT increasing doses of birch pollen solutions are applied to the eye and
characteristic symptoms (eye redness, weeping, itching or burning and nose
dripping/blockage) are assessed: 0 = absent, 1=mild, 2=moderate, 3=severe). At a score value
of >= 5/concentration the test is considered positive and finished.
It is expected that at the end of the study higher doses are necessary to provoke a positive
CPT.
Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups
is a very important parameter for the evaluation of the outcome of the study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment