Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

NCT ID: NCT01052610

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-09-30

Brief Summary

The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

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 possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Conditions

Bronchial Asthma; Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active group

Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract

Group Type: ACTIVE_COMPARATOR

sublingual house dust mites allergen extract

Intervention Type: DRUG

Staloral 300 IR, Stallergenes, France

Placebo group

Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator

Group Type: PLACEBO_COMPARATOR

placebo in sublingual applicator

Intervention Type: DRUG

placebo for Staloral 300 IR, Stallergenes, France

Interventions

sublingual house dust mites allergen extract

Staloral 300 IR, Stallergenes, France

Intervention Type: DRUG

placebo in sublingual applicator

placebo for Staloral 300 IR, Stallergenes, France

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study

Exclusion Criteria

• active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
• hospitalisation due to asthma exacerbation during the 3 months before the first visit
• known contraindications of SIT according to the EAACI
• previous allergen immunotherapy
• use of systemic corticosteroids
• other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Iwona Stelmach

MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iwona Stelmach, MD, PhD, Prof

Role: STUDY_CHAIR

Department of Pediatrics and Allergy

Locations

Department of Pediatrics and Allergy

Lodz, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Iwona Stelmach, MD, PhD, Prof

Role: CONTACT

alergol@kopernik.lodz.pl

+48426895972

Facility Contacts

Monika Bobrowska-Korzeniowska, MD, PhD

Role: primary

alergol@kopernik.lodz.pl

426895972

Other Identifiers

502-12-760, 503-2056-1

Identifier Type: -

Identifier Source: org_study_id