- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00955825
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Illinois
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Normal, Illinois, United States, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
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Kentucky
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Lexington, Kentucky, United States, 40508
- University of Kentucky Medical Center
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Owensboro, Kentucky, United States, 42301
- Allergy & Asthma Specialists, PSC
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins University
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Michigan
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Ypsilanti, Michigan, United States, 48197
- Respiratory Medical Research Institute of Michigan PLC
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Missouri
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Columbia, Missouri, United States, 65203
- Clinical Research of The Ozarks, Inc.
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St. Louis, Missouri, United States, 63141
- Midwest Clinical Research LLC
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Warrensburg, Missouri, United States, 64093
- Clinical Research of the Ozarks, Inc
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Montana
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Billings, Montana, United States, 59101
- Montana Allergy & Asthma Specialists
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Missoula, Montana, United States, 59808
- Montana Medical Research
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University - Allergy & Asthma
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Ohio
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Cincinatti, Ohio, United States, 45231
- Bernstein Clinical Research Center, LLC
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Oregon
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Eugene, Oregon, United States, 97401
- Allergy and Asthma Research Group
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Lake Oswego, Oregon, United States, 97035
- Baker Allergy, Asthma, & Dermatology Research Center, LLC
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Medford, Oregon, United States, 97504
- Clinical Research Institute of Southern Oregon, P.C.
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Portland, Oregon, United States, 97213
- Allergy Associates Research
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15241
- Allergy & Clinical Immunology Associates
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University Medical Center
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Washington
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Vancouver, Washington, United States, 98664
- North West Asthma Allergy Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 300 IR
300 IR grass pollen allergen extract tablet
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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
Other Names:
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Placebo Comparator: Placebo
Pacebo tablet
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Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined Score (CS)
Time Frame: Pollen period (average of 42.8 days)
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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. |
Pollen period (average of 42.8 days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: COX Linda, MD, Allergists and Immunologists - Fort Lauderdale - Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VO61.08 USA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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