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

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
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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
|
- 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) ]
- 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) ]

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

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
Contact: Iwona Stelmach, MD, PhD, Prof | +48426895972 | alergol@kopernik.lodz.pl |
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 |
Study Chair: | Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy |
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:
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 |