Grass Pollen-related Allergic Rhinoconjunctivitis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From Grass Pollen Rhinoconjunctivitis
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Allergy is one of the most common chronic disease in the world currently affecting between
10% and 25% of the general population.
Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic
rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal
itching and itchy, watery, red and swollen eyes.
Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms,
immunotherapy is considered more appropriate for patients in whom these symptoms are not
optimally controlled with relief medications.
In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy
nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief
medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral
corticosteroid) reported daily during the grass pollen season.
Efficacy and good safety profile of 300IR SLIT tablet administered once per day for
approximately six months (starting 4 months before and over the season) will be demonstrated
during the grass pollen season compared to placebo.
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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