Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01052610
• Other study ID #: 502-12-760, 503-2056-1
• Status: Recruiting
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: February 6, 2013
• Start date: June 2010
• Est. completion date: September 2013

Study information

• Verified date: February 2013
• Source: Medical Universtity of Lodz
• Contact: Iwona Stelmach, MD, PhD, Prof
• Phone: +48426895972
• Email: alergol[@]kopernik.lodz.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Bronchial Asthma
• Rhinitis

Intervention

Drug:
• sublingual house dust mites allergen extract
Staloral 300 IR, Stallergenes, France
• placebo in sublingual applicator
placebo for Staloral 300 IR, Stallergenes, France

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No