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

NCT00518518 | Completed Phase 4 DMC

• 1 other identifier: RNN-3-06-KE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Sublingual immunotherapy; Children

Outcome Measures

Primary Outcomes (1)

• clinical symptoms, reliever drugs usage, controller medication usage, lung function

  all visits

Secondary Outcomes (3)

• 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)

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Staloral 300

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Staloral 300 DRUG

Staloral 300

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

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

Lodz, 93-513, Poland

Location

Related Publications (1)

• Stelmach I, Kaczmarek-Wozniak J, Majak P, Olszowiec-Chlebna M, Jerzynska J. Efficacy and safety of high-doses sublingual immunotherapy in ultra-rush scheme in children allergic to grass pollen. Clin Exp Allergy. 2009 Mar;39(3):401-8. doi: 10.1111/j.1365-2222.2008.03159.x. Epub 2008 Dec 23.

  PMID: 19134016 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Joanna Kaczmarek, MD

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

  PRINCIPAL INVESTIGATOR

• Iwona Stelmach, MD, PhD, Prof

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 20, 2007
• Study Start: March 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

PL (1)