Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052610

Enrollment

100

Registered

2010-01-20

Start date

2010-06-30

Completion date

2013-09-30

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Bronchial Asthma

Keywords

SLIT, bronchial asthma, allergic rhinitis

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.

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.

Interventions

DRUGsublingual house dust mites allergen extract

Staloral 300 IR, Stallergenes, France

DRUGplacebo in sublingual applicator

placebo for Staloral 300 IR, Stallergenes, France

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Secondary

Measure	Time frame
non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test	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	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	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Countries

Poland

Contacts

Primary ContactIwona Stelmach, MD, PhD, Prof

alergol@kopernik.lodz.pl+48426895972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026