Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Rhinitis; Bronchial Asthma
• Intervention / Treatment: Drug: sublingual house dust mites allergen extract; Drug: placebo in sublingual applicator

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 93-513
    • Recruiting
    • Department of Pediatrics and Allergy
    • Contact: Monika Bobrowska-Korzeniowska, MD, PhD; Phone Number: 426895972; Email: alergol@kopernik.lodz.pl
    • Principal Investigator: Monika Bobrowska-Korzeniowska, MD, PhD
    • Sub-Investigator: Agnieszka Brzozowska, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active group; Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract	Drug: sublingual house dust mites allergen extract; Staloral 300 IR, Stallergenes, France
Placebo Comparator: Placebo group; Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator	Drug: placebo in sublingual applicator; placebo for Staloral 300 IR, Stallergenes, France

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of percent of regulatory lymphocytes in peripheral blood	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
assessment of inflammatory markers in exhaled breath condensate and FeNO	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Study Chair: Iwona Stelmach, MD, PhD, Prof, Department of Pediatrics and Allergy

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: allergic rhinitis; bronchial asthma; SLIT
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 502-12-760, 503-2056-1