Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Staloral 300; Drug: placebo

• Registration Number: NCT00518518
• Lead Sponsor: Medical University of Lodz

Brief Summary

The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of sublingual immunotherapy (SLIT) in children with asthma.

Detailed Description

Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy.

The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma.

After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-14
• Last Update Posted: 2009-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients allergic to grasses pollen
• patients with bronchial asthma
• patients with controlled asthma
• patients who were qualified for immunotherapy and gave written informed consent for immunotherapy

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Exclusion Criteria

• patients allergic for other perennial and seasonal allergens
• patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Staloral 300	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
clinical symptoms, reliever drugs usage, controller medication usage, lung function	all visits

Secondary Outcome Measures

Name	Time	Method
chosen markers of inflammation (specific IgE, IgG4, eosinophils)	1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit)
skin prick test, specific nasal provocation test with grass pollen allergen	baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit)
bronchial hyperreactivity with methacholine	after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit)

Trial Locations

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz, Poland; 🇵🇱 Lodz, Poland