Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Bronchial Asthma; Allergic Rhinitis	Drug: sublingual house dust mites allergen extract; Drug: placebo in sublingual applicator	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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 Start Date :	June 2010
Estimated Primary Completion Date :	September 2013
Estimated Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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 Measures :

1. 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) ]
2. 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) ]
3. 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) ]

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Iwona Stelmach, MD, PhD, Prof	+48426895972	alergol@kopernik.lodz.pl

Locations

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

Sponsors and Collaborators

Medical Universtity of Lodz

Investigators

Study Chair:	Iwona Stelmach, MD, PhD, Prof	Department of Pediatrics and Allergy

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT01052610 History of Changes
Other Study ID Numbers:	502-12-760, 503-2056-1
First Posted:	January 20, 2010
Last Update Posted:	February 7, 2013
Last Verified:	February 2013

Keywords provided by Iwona Stelmach, Medical Universtity of Lodz:

SLIT; bronchial asthma; allergic rhinitis

Additional relevant MeSH terms:

Asthma; Rhinitis; Rhinitis, Allergic; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases