Status:
COMPLETED
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
Lead Sponsor:
Stallergenes Greer
Conditions:
Allergic Rhinitis Due to Grass Pollens
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Positive SPT to grasses
- Total symptoms score for the previous pollen season more than 12 out of 18.
- Patients with FEV1 ≥ 80% of the predicted value.
Exclusion
- Positive SPT to other grasses present during the grass pollen season and if endemic to the region
- Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
- Asthma requiring treatment with medications other than beta-2 inhaled agonists.
- Patients who have received any desensitization treatment for grass pollen in the past 5 years.
- Ongoing immunotherapy with any other allergen.
- Patients with any nasal or oral condition that could confound the efficacy or safety assessments
- Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance).
- 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.
- Patients treated with systemic or inhaled corticosteroids
- Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
- Pregnant, breastfeeding, or sexually active women who are not using a medically accepted contraceptive method as listed above.
- Patients participating or having participated within 30 days before Screening in any clinical study.
- 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
- Patients with history of drug or alcohol abuse.
- 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.
- Patients will not be randomized in this study more than once.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00955825
Start Date
October 1 2008
End Date
August 1 2009
Last Update
May 19 2016
Active Locations (19)
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1
Sneeze, wheeze, and Itch Associates, LLC
Normal, Illinois, United States, 61761
2
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40508
3
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States, 42301
4
Johns Hopkins University
Baltimore, Maryland, United States, 21224