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

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergic Rhinitis Due to Grass Pollens

In brief

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.

Key facts

Study ID

NCT00955825

Run by

Stallergenes Greer

People needed

473

Starts

2008-10-01

Expected to finish

2009-08-01

Last updated by the study team

2016-05-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sneeze, wheeze, and Itch Associates, LLC — Normal, Illinois, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Allergy & Asthma Specialists, PSC — Owensboro, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Respiratory Medical Research Institute of Michigan PLC — Ypsilanti, Michigan, United States
• Clinical Research of the Ozarks, Inc. — Columbia, Missouri, United States
• Midwest Clinical Research LLC — St Louis, Missouri, United States
• Clinical Research of the Ozarks, Inc — Warrensburg, Missouri, United States
• Montana Allergy & Asthma Specialists — Billings, Montana, United States
• Montana Medical Research — Missoula, Montana, United States
• Creighton University - Allergy & Asthma — Omaha, Nebraska, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Allergy and Asthma Research Group — Eugene, Oregon, United States
• Baker Allergy, Asthma, & Dermatology Research Center, LLC — Lake Oswego, Oregon, United States
• Clinical Research Institute of Southern Oregon, P.C. — Medford, Oregon, United States
• Allergy Associates Research — Portland, Oregon, United States
• Allergy & Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• North West Asthma Allergy Center — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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