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

Sponsored by:	Medical Universtity of Lodz
Information provided by:	Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT00698594

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Biological: sublingual allergen extract Biological: placebo	Phase IV

U.S. FDA Resources

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

Further study details as provided by Medical Universtity of Lodz:

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 ]

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 ]

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	Biological: 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=30) - seasonal SLIT group
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	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=30) - yearly SLIT group
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	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

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.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698594

Locations

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

Sponsors and Collaborators

Medical Universtity of Lodz

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

More Information

Responsible Party:	Department of Pediatrics and Allergy, Medical University of Lodz, Poland ( Iwona Stelmach MD, PhD, Prof )
Study ID Numbers:	RNN/98/08/KE
Study First Received:	June 13, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00698594
Health Authority:	Poland: Ministry of Health

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis

Additional relevant MeSH terms:

Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009