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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518518
• Other study ID #: RNN-3-06-KE
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2007
• Last updated: May 14, 2009
• Start date: March 2006
• Est. completion date: November 2008

Study information

• Verified date: May 2009
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Staloral 300
Staloral 300
• placebo
placebo

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

References & 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.1365-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical symptoms, reliever drugs usage, controller medication usage, lung function		all visits	Yes
Secondary	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)	No
Secondary	skin prick test, specific nasal provocation test with grass pollen allergen		baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit)	No
Secondary	bronchial hyperreactivity with methacholine		after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit)	No