Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis

NCT ID: NCT00698594

Last Updated: 2011-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.

Detailed Description

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.

Conditions

Allergic Rhinitis

Study Design

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

Study Groups

1

Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group

Group Type: ACTIVE_COMPARATOR

sublingual allergen extract

Intervention Type: BIOLOGICAL

Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group

2

Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group

Group Type: ACTIVE_COMPARATOR

sublingual allergen extract

Intervention Type: BIOLOGICAL

Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group

3

Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group

Interventions

sublingual allergen extract

Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group

Intervention Type: BIOLOGICAL

sublingual allergen extract

Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group

Intervention Type: BIOLOGICAL

placebo

Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group

Intervention Type: BIOLOGICAL

Other Intervention Names

Staloral 300 IR, Stallergenes, France; Staloral 300 IR, Stallergenes, France

Eligibility Criteria

Inclusion Criteria

• Children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed at least 2 years before inclusion into the study

Exclusion Criteria

• Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
• Allergic rhinitis hospitalisation during the 3 months before the first visit.
• Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
• Excluded medications were systemic corticosteroids.
• Patients who were receiving immunotherapy were also excluded.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Iwona Stelmach

Head of the Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, MD, PhD, Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iwona Stelmach, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Locations

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Lodz, Łódź Voivodeship, Poland

Countries

Poland

Other Identifiers

RNN/98/08/KE

Identifier Type: -

Identifier Source: org_study_id