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

NCT00698594 | Completed Phase 4 DMC

• 1 other identifier: RNN/98/08/KE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (3)

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=20) - seasonal SLIT group

Biological: sublingual allergen extract

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=20) - yearly SLIT group

Biological: sublingual allergen extract

3

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Staloral 300 IR, Stallergenes, France

1

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

3

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

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

Lodz, Łódź Voivodeship, Poland

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Iwona Stelmach, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, MD, PhD, Prof.

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 22, 2011

Record last verified: 2011-08

Locations

PL (1)