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Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Primary Purpose

Bronchial Asthma, Allergic Rhinitis

Status

Unknown status

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

sublingual house dust mites allergen extract

placebo in sublingual applicator

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring SLIT, bronchial asthma, allergic rhinitis

Eligibility Criteria

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

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

Sites / Locations

Department of Pediatrics and AllergyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical symptoms of asthma and allergic rhinitis and use of rescue medication

Secondary Outcome Measures

Change of percent of regulatory lymphocytes in peripheral blood

assessment of inflammatory markers in exhaled breath condensate and FeNO

non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test

Full Information

NCT ID

NCT01052610

First Posted

January 12, 2010

Last Updated

February 6, 2013

Sponsor

Medical University of Lodz

1. Study Identification

Unique Protocol Identification Number

NCT01052610

Brief Title

Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Lodz

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Bronchial Asthma, Allergic Rhinitis

Keywords

SLIT, bronchial asthma, allergic rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sublingual house dust mites allergen extract

Intervention Description

Staloral 300 IR, Stallergenes, France

Intervention Type

Drug

Intervention Name(s)

placebo in sublingual applicator

Intervention Description

placebo for Staloral 300 IR, Stallergenes, France

Primary Outcome Measure Information:

Title

Clinical symptoms of asthma and allergic rhinitis and use of rescue medication

Time Frame

Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Secondary Outcome Measure Information:

Title

Change of percent of regulatory lymphocytes in peripheral blood

Time Frame

Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Title

assessment of inflammatory markers in exhaled breath condensate and FeNO

Time Frame

Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Title

non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test

Time Frame

Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Iwona Stelmach, MD, PhD, Prof

Phone

+48426895972

alergol@kopernik.lodz.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iwona Stelmach, MD, PhD, Prof

Organizational Affiliation

Department of Pediatrics and Allergy

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Pediatrics and Allergy

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Monika Bobrowska-Korzeniowska, MD, PhD

Phone

426895972

alergol@kopernik.lodz.pl

First Name & Middle Initial & Last Name & Degree

Monika Bobrowska-Korzeniowska, MD, PhD

First Name & Middle Initial & Last Name & Degree

Agnieszka Brzozowska, MD, PhD

12. IPD Sharing Statement

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Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

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