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Sponsored by: |
Medical Universtity of Lodz |
Information provided by: | Medical Universtity of Lodz |
ClinicalTrials.gov Identifier: | NCT00698594 |
The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
Condition | Intervention | Phase |
Allergic Rhinitis |
Biological: sublingual allergen extract (Staloral 300 IR, Stallergenes, France) Biological: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis Allergic to Grass Pollen |
Estimated Enrollment: | 90 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=30) - seasonal SLIT group
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Biological: sublingual allergen extract (Staloral 300 IR, Stallergenes, France)
Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=30) - seasonal SLIT group
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2: Active Comparator
Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=30) - yearly SLIT group
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Biological: sublingual allergen extract (Staloral 300 IR, Stallergenes, France)
Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=30) - yearly SLIT group
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3: Placebo Comparator
Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=30) - placebo group
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Biological: placebo
Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=30) - placebo group
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Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However efficacy and safety of sublingual immunotherapy are still important issues, especially in children.
The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Izabela Kałuzińska- Parzyszek, MD | 48-42-689-5972 |
Poland | |||||
Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Recruiting | ||||
Lodz, Poland | |||||
Contact: Izabela Kałuzińska-Parzyszek, MD 48-42-689-5972 |
Medical Universtity of Lodz |
Principal Investigator: | Izabela Kałuzińskiej- Parzyszek, MD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
Study Chair: | Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
Responsible Party: | Department of Pediatrics and Allergy, Medical University of Lodz, Poland ( Iwona Stelmach MD, PhD, Prof ) |
Study ID Numbers: | RNN/98/08/KE |
First Received: | June 13, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698594 |
Health Authority: | Poland: Ministry of Health |
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