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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00955825
First received: August 3, 2009
Last updated: December 11, 2012
Last verified: December 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • 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 ]

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 ]
  • 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 ]
  • 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 ]

Enrollment: 473
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active group
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 Comparator: Placebo group
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
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
Investigators
Principal Investigator: COX Linda, MD Allergists and Immunologists - Fort Lauderdale - Florida
  More Information

No publications provided by Stallergenes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00955825     History of Changes
Other Study ID Numbers: VO61.08 USA
Study First Received: August 3, 2009
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Stallergenes:
allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014