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Completed

NCT Number: NCT00698594

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Lodz, Łódź Voivodeship, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sublingual allergen extract

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

Other names: Staloral 300 IR, Stallergenes, France

Placebo

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

Primary outcomes

  1. Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)

    Time frame: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.

    Visit 2 (6 months after starting the study), visit 3 (9 months after starting the study), visit 4 (12 months after starting the study), visit 5 (18 months after starting the study), visit 6 (21 months after starting the study), visit 7 (24 months after starting the study).

Secondary outcomes

  1. Change of percent of regulatory lymphocytes in the peripheral blood.

    Time frame: at baseline and at the end of the second season (22 months interval)

  2. non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.

    Time frame: at the end of the first and second season of the study (12 months interval)

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2008
Registry last updated
Aug 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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