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

NCT00518518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Staloral 300

Staloral 300

DRUG

placebo

placebo

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Joanna Kaczmarek, MD · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

  • Iwona Stelmach, MD, PhD, Prof · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00518518 on ClinicalTrials.gov