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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00698594
First received: June 13, 2008
Last updated: August 19, 2011
Last verified: August 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
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=20) - seasonal SLIT group
Other Name: Staloral 300 IR, Stallergenes, France
Active Comparator: 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
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
Other Name: Staloral 300 IR, Stallergenes, France
Placebo Comparator: 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
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
Other Name: placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Iwona Stelmach, Prof. Department of Pediatrics and Allergy, Medical University of Lodz, Poland
  More Information

No publications provided

Responsible Party: Iwona Stelmach, Head of the Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, MD, PhD, Prof., Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT00698594     History of Changes
Other Study ID Numbers: RNN/98/08/KE
Study First Received: June 13, 2008
Last Updated: August 19, 2011
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014