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NCT Number: NCT00518518

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Lodz, 93-513, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Staloral 300

Drug

Staloral 300

Placebo

Drug

placebo

Primary outcomes

  1. clinical symptoms, reliever drugs usage, controller medication usage, lung function

    Time frame: all visits

Secondary outcomes

  1. chosen markers of inflammation (specific IgE, IgG4, eosinophils)

    Time frame: 1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit)

  2. skin prick test, specific nasal provocation test with grass pollen allergen

    Time frame: baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit)

  3. bronchial hyperreactivity with methacholine

    Time frame: after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit)

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

Safety and Efficacy of Ultra-Rush High-Dose Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen - Prospective, Randomized, Placebo Controlled Study.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2007
Registry last updated
May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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