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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
sublingual allergen extract
sublingual allergen extract
placebo
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
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.
non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.

Full Information

First Posted
June 13, 2008
Last Updated
August 19, 2011
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT00698594
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
sublingual allergen extract
Other Intervention Name(s)
Staloral 300 IR, Stallergenes, France
Intervention Description
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
Intervention Name(s)
sublingual allergen extract
Other Intervention Name(s)
Staloral 300 IR, Stallergenes, France
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
Description
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).
Time Frame
Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.
Secondary Outcome Measure Information:
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, Prof.
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
City
Lodz
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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