To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
placebo tablet given once daily over 60 days
Research facility ID ORG-001086
Moscow, Russia
Research facility ID ORG-001018
Moscow, Russia
Research facility ID ORG-001005
Moscow, Russia
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
measurement of IgG4 in serum
Time frame: baseline versus end of treatment (approx. 60 days)
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
measurement of IgE in serum
Time frame: baseline versus end of treatment (approx. 60 days)
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Research facility ID ORG-001009
Moscow, Russia
Research facility ID ORG-001016
Moscow, Russia
Research facility ID ORG-001006
Moscow, Russia
Research facility ID ORG-001085
Moscow, Russia
Research facility ID ORG-001014
Moscow, Russia
Research facility ID ORG-001007
Saint Petersburg, Russia
Research facility ID ORG-001019
Saint Petersburg, Russia
...and 5 more locations