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Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

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ClinicalTrials.gov Identifier: NCT01052610
Recruitment Status : Unknown
Verified February 2013 by Iwona Stelmach, Medical Universtity of Lodz.
Recruitment status was:  Recruiting
First Posted : January 20, 2010
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Odactra

Arms and Interventions
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052610


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

Locations
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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
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Study Chair: Iwona Stelmach, MD, PhD, Prof Department of Pediatrics and Allergy
More Information
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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    Key Record Dates
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:
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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