Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis - Full Text View

Sponsored by:	Stallergenes
Information provided by:	Stallergenes
ClinicalTrials.gov Identifier:	NCT00955825

Purpose

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.

Condition	Intervention	Phase
Grass Pollen-related Allergic Rhinoconjunctivitis	Biological: Grass pollen allergen extract Drug: Placebo tablet	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Stallergenes:

Primary Outcome Measures:

Average Adjusted Symptom Score (AASS): score taking account RTSS and rescue medication use. Symptom score will be adjusted according to the rescue medication use. AASS is calculated as the average of valid data during the pollen period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average Rhinoconjunctivitis Total Symptom Score (ARTSS): severity of the six rhinoconjunctivitis symptoms are evaluated daily and the daily total score recorded. ARTSS will be calculated as the average of all valid data during the pollen period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Average Rescue Medication Score (ARMS): daily rescue medication use and corresponding score will be recorded. ARMS will be calculated as the average of all valid data during the pollen period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Average Combined Score (ACS): combined score will be calculated taking into account patient's daily RTSS ane RMS assuming equal weight for both scores. ACS will be calculated as the average of daily CS during the pollen period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of Symptom-controlled Days (PSCD): Symptom-controlled days are days where RMS is equal to 0 and RTSS under a pre-defined threshold. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	473
Study Start Date:	October 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active group: Experimental Sublingual tablet of grass pollen allergen extract	Biological: Grass pollen allergen extract 300IR sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Placebo group: Placebo Comparator Sublingual tablet of placebo	Drug: Placebo tablet Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955825

Locations

United States, Illinois
Sneeze, wheeze, and Itch Associates, LLC
Normal, Illinois, United States, 61761
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40508
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States, 42301
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Michigan
Respiratory Medical Research Institute of Michigan PLC
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Clinical Research of the Ozarks, Inc
Warrensburg, Missouri, United States, 64093
Clinical Research of the Ozarks, Inc.
Columbia, Missouri, United States, 65203
Midwest Clinical Research LLC
St. Louis, Missouri, United States, 63141
United States, Montana
Montana Allergy & Asthma Specialists
Billings, Montana, United States, 59101
Montana Medical Research
Missoula, Montana, United States, 59808
United States, Nebraska
Creighton University - Allergy & Asthma
Omaha, Nebraska, United States, 68131
United States, Ohio
Bernstein Clinical Research Center, LLC
Cincinatti, Ohio, United States, 45231
United States, Oregon
Allergy and Asthma Research Group
Eugene, Oregon, United States, 97401
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, United States, 97504
Baker Allergy, Asthma, & Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
Allergy Associates Research
Portland, Oregon, United States, 97213
United States, Pennsylvania
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
United States, Washington
North West Asthma Allergy Center
Vancouver, Washington, United States, 98664

Sponsors and Collaborators

Stallergenes

Investigators

Principal Investigator:

COX Linda, MD

Allergists and Immunologists - Fort Lauderdale - Florida

More Information

No publications provided

Responsible Party:	STALLERGENES ( Dr MELAC )
Study ID Numbers:	VO61.08 USA
Study First Received:	August 3, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955825 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stallergenes:

allergic rhinoconjunctivitis

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on September 11, 2009