Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
Condition: Allergic Rhinitis Due to Grass Pollens
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: 300 IR; Placebo
Intervention description: 300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season; Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 473.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: allergic rhinoconjunctivitis

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen
             seasons.

          2. Positive SPT to grasses

          3. Total symptoms score for the previous pollen season more than 12 out of 18.

          4. Patients with FEV1 ≥ 80% of the predicted value.

        Exclusion Criteria:

          1. Positive SPT to other grasses present during the grass pollen season and if endemic to
             the region

          2. Patients with clinically significant confounding symptoms of allergy to other
             allergens potentially overlapping the grass pollen season

          3. Asthma requiring treatment with medications other than beta-2 inhaled agonists.

          4. Patients who have received any desensitization treatment for grass pollen in the past
             5 years.

          5. Ongoing immunotherapy with any other allergen.

          6. Patients with any nasal or oral condition that could confound the efficacy or safety
             assessments

          7. Patients with known history of hypersensitivity or intolerance to any of the
             excipients in the investigational product (such as lactose intolerance).

          8. Patients with any past or current clinically significant condition which as judged by
             the investigator, may affect the patient's participation or the outcome of the study.

          9. Patients treated with systemic or inhaled corticosteroids

         10. Patients treated or under treatment with beta-blockers, continuous systemic
             corticotherapy or immunosuppressive drugs.

         11. Pregnant, breastfeeding, or sexually active women who are not using a medically
             accepted contraceptive method as listed above.

         12. Patients participating or having participated within 30 days before Screening in any
             clinical study.

         13. Patients who are unlikely to complete the study for any reason, or patients who have
             to travel for extended periods of time during the grass pollen season which will
             compromise the data

         14. Patients with history of drug or alcohol abuse.

         15. Study staff, investigators, sub-investigators, as well as their children or spouses
             and family members of all study staff should not be enrolled in the study.

         16. Patients will not be randomized in this study more than once.