Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Allergy Clinical Trial

Official title:

A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191359
• Other study ID #: SP-B-02
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2010
• Last updated: February 7, 2013
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2013
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• A history of Birch pollen allergy

• Positive skin prick test to birch

• Positive specific IgE to birch

Exclusion criteria:

• Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment)

• Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years

• Concomitant SLIT with any allergen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• oral immunotherapy
orally applied specific immunotherapy

Locations

Country	Name	City	State
Germany	Universitätsklinik Bonn, Dermatology	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch	specific antibody determination	after 4, 8, 12, 24, 36 weeks of treatment	No
Secondary	Comparison of the two administration routes with regard to safety aspects	adverse events	36 weeks	Yes