Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Interventions
- Drug: 300 IRDrug: Placebo
- Registration Number
- NCT00955825
- Lead Sponsor
- Stallergenes Greer
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 473
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 300 IR 300 IR 300 IR grass pollen allergen extract tablet Placebo Placebo Pacebo tablet
- Primary Outcome Measures
Name Time Method Combined Score (CS) Pollen period (average of 42.8 days) The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.
The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).
The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Allergy & Asthma Specialists, PSC
🇺🇸Owensboro, Kentucky, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
Clinical Research of the Ozarks, Inc.
🇺🇸Columbia, Missouri, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Montana Allergy & Asthma Specialists
🇺🇸Billings, Montana, United States
Sneeze, wheeze, and Itch Associates, LLC
🇺🇸Normal, Illinois, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Midwest Clinical Research LLC
🇺🇸St. Louis, Missouri, United States
Clinical Research of the Ozarks, Inc
🇺🇸Warrensburg, Missouri, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinatti, Ohio, United States
Allergy & Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
North West Asthma Allergy Center
🇺🇸Vancouver, Washington, United States
Allergy and Asthma Research Group
🇺🇸Eugene, Oregon, United States
Baker Allergy, Asthma, & Dermatology Research Center, LLC
🇺🇸Lake Oswego, Oregon, United States
Allergy Associates Research
🇺🇸Portland, Oregon, United States
Clinical Research Institute of Southern Oregon, P.C.
🇺🇸Medford, Oregon, United States
Respiratory Medical Research Institute of Michigan PLC
🇺🇸Ypsilanti, Michigan, United States
Creighton University - Allergy & Asthma
🇺🇸Omaha, Nebraska, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States