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Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

This study is currently recruiting participants.
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01052610
First received: January 12, 2010
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Bronchial Asthma
Allergic Rhinitis
 Drug: sublingual house dust mites allergen extract
Drug: placebo in sublingual applicator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052610

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

No publications provided

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
Study First Received: January 12, 2010
Last Updated: February 6, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
SLIT
bronchial asthma
allergic rhinitis

Additional relevant MeSH terms:
Asthma
Rhinitis
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

ClinicalTrials.gov processed this record on May 21, 2013