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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

December 23, 2008

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire) [ Time Frame: visit no: 2 , 4 , 6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change of percent of regulatory lymphocytes in the peripheral blood. [ Time Frame: visit no 3, 4, 5, 6 ] [ Designated as safety issue: No ]
non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test. [ Time Frame: visit no: 2, 4, 6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Allergic Rhinitis

Intervention ^†

Biological: sublingual allergen extract
Biological: placebo

Study Arms / Comparison Groups

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
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
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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

Estimated Completion Date

September 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Poland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698594

Responsible Party

Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Secondary IDs ^††

Study Sponsor ^†

Medical Universtity of Lodz

Collaborators ^††

Investigators ^†

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

Information Provided By

Medical Universtity of Lodz

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.