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Sponsored by: |
Stallergenes |
---|---|
Information provided by: | Stallergenes |
ClinicalTrials.gov Identifier: | NCT00674700 |
The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Drug: Sublingual Immunotherapy Tablets of house dust mites allergen extract Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, DBPC, Multi-National Phase II/III Study of the Safety and Efficacy of Two Doses of Sublingual Immunotherapy (SLIT) Administered as Allergen-Based Tablets Once Daily to Adult Patients Suffering From HDM Allergic Rhinitis |
Enrollment: | 509 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A, 1: Active Comparator
162 active patients with house dust mites related allergic rhinitis receiving 300IR allergen- based tablets
|
Drug: Sublingual Immunotherapy Tablets of house dust mites allergen extract
House dust mite allergen-based tablets, 300 IR, once daily, 12 months
|
A, 2: Active Comparator
162 active patients with house dust mite allergic rhinitis receiving 500 IR allergen-based tablets
|
Drug: Sublingual Immunotherapy Tablets of house dust mites allergen extract
House dust mite allergen-based tablets, 500 IR, once daily, 12 months
|
A, 3: Placebo Comparator
162 patients with house dust mite allergic rhinitis receiving placebo tablets
|
Drug: placebo
placebo tablets, once daily, 12 months
|
Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis.
In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration.
After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | STALLERGENES ( MELAC ) |
Study ID Numbers: | VO57.07 |
Study First Received: | May 6, 2008 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00674700 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Czech Republic: State Institute for Drug Control; Germany: Paul-Ehrlich-Institut; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; Spain: Ministry of Health and Consumption |
House dust mites allergy |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis |
Nose Diseases |