Viewing Study NCT00518518



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00518518
Status: COMPLETED
Last Update Posted: 2009-05-15
First Post: 2007-08-17

Brief Title: Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen
Sponsor: Medical University of Lodz
Organization: Medical University of Lodz

Study Overview

Official Title: Safety and Efficacy of Ultra-Rush High-Dose Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen - Prospective Randomized Placebo Controlled Study
Status: COMPLETED
Status Verified Date: 2009-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None