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

NCT ID: NCT00955825

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-08-31

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.

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.

Conditions

Allergic Rhinitis Due to Grass Pollens

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

300 IR

300 IR grass pollen allergen extract tablet

Group Type: EXPERIMENTAL

300 IR

Intervention Type: DRUG

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

Placebo

Pacebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Sublingual immunotherapy tablet; Sublingual placebo tablet

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stallergenes Greer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

COX Linda, MD

Role: PRINCIPAL_INVESTIGATOR

Allergists and Immunologists - Fort Lauderdale - Florida

Locations

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

Countries

United States

References

Cox LS, Casale TB, Nayak AS, Bernstein DI, Creticos PS, Ambroisine L, Melac M, Zeldin RK. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012 Dec;130(6):1327-34.e1. doi: 10.1016/j.jaci.2012.08.032. Epub 2012 Oct 31.

Reference Type: RESULT

PMID: 23122534 (View on PubMed)

Other Identifiers

VO61.08 USA

Identifier Type: -

Identifier Source: org_study_id