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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00955825
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Due to Grass Pollens Drug: 300 IR Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 300 IR
300 IR grass pollen allergen extract tablet
Drug: 300 IR
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 Name: Sublingual immunotherapy tablet
Placebo Comparator: Placebo
Pacebo tablet
Drug: Placebo
Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Other Name: Sublingual placebo tablet

Primary Outcome Measures :
  1. Combined Score (CS) [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00955825

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.
Columbia, Missouri, United States, 65203
Midwest Clinical Research LLC
St. Louis, Missouri, United States, 63141
Clinical Research of the Ozarks, Inc
Warrensburg, Missouri, United States, 64093
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
Baker Allergy, Asthma, & Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, United States, 97504
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 Greer
Principal Investigator: COX Linda, MD Allergists and Immunologists - Fort Lauderdale - Florida

Publications of Results:
Responsible Party: Stallergenes Greer Identifier: NCT00955825     History of Changes
Other Study ID Numbers: VO61.08 USA
First Posted: August 10, 2009    Key Record Dates
Results First Posted: May 19, 2016
Last Update Posted: May 19, 2016
Last Verified: April 2016

Keywords provided by Stallergenes Greer:
allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases