Grass Pollen-related Allergic Rhinoconjunctivitis Clinical Trial
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
| Verified date | December 2009 |
| Source | Stallergenes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 473 |
| Est. completion date | August 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Montana Allergy & Asthma Specialists | Billings | Montana |
| United States | Bernstein Clinical Research Center, LLC | Cincinatti | Ohio |
| United States | Clinical Research of the Ozarks, Inc. | Columbia | Missouri |
| United States | Allergy and Asthma Research Group | Eugene | Oregon |
| United States | Baker Allergy, Asthma, & Dermatology Research Center, LLC | Lake Oswego | Oregon |
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| United States | Clinical Research Institute of Southern Oregon, P.C. | Medford | Oregon |
| United States | Montana Medical Research | Missoula | Montana |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Sneeze, wheeze, and Itch Associates, LLC | Normal | Illinois |
| United States | Creighton University - Allergy & Asthma | Omaha | Nebraska |
| United States | Allergy & Asthma Specialists, PSC | Owensboro | Kentucky |
| United States | Allergy & Clinical Immunology Associates | Pittsburgh | Pennsylvania |
| United States | Allergy Associates Research | Portland | Oregon |
| United States | Midwest Clinical Research LLC | St. Louis | Missouri |
| United States | North West Asthma Allergy Center | Vancouver | Washington |
| United States | Clinical Research of the Ozarks, Inc | Warrensburg | Missouri |
| United States | Respiratory Medical Research Institute of Michigan PLC | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Stallergenes |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 months | No | |
| Secondary | 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. | 6 months | No | |
| Secondary | 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 | 6 months | No | |
| Secondary | Proportion of Symptom-controlled Days (PSCD): Symptom-controlled days are days where RMS is equal to 0 and RTSS under a pre-defined threshold. | 6 months | No | |
| Secondary | 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. | 6 months | No |