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

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ClinicalTrials.gov Identifier: NCT00518518
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : May 15, 2009
Sponsor:
Information provided by:
Medical Universtity 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Staloral 300 Drug: placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : March 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Staloral 300
Staloral 300
Placebo Comparator: 2 Drug: placebo
placebo



Primary Outcome Measures :
  1. clinical symptoms, reliever drugs usage, controller medication usage, lung function [ Time Frame: all visits ]

Secondary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518518


Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, Poland, 93-513
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Joanna Kaczmarek, MD Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD, PhD, Prof Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Publications of Results:
Responsible Party: Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland.
ClinicalTrials.gov Identifier: NCT00518518     History of Changes
Other Study ID Numbers: RNN-3-06-KE
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by Medical Universtity of Lodz:
Asthma
Sublingual immunotherapy
Children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases