Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2013 by Iwona Stelmach, Medical Universtity of Lodz.
Recruitment status was: Recruiting

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 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

Further study details as provided by Iwona Stelmach, 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) ]

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) ]
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) ]
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) ]


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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

ClinicalTrials.gov processed this record on August 18, 2017

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