Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ALK-Abelló A/S

ClinicalTrials.gov Identifier:

NCT01191359

First received: August 27, 2010

Last updated: February 7, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 27, 2010

Last Updated Date

February 7, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch [ Time Frame: after 4, 8, 12, 24, 36 weeks of treatment ] [ Designated as safety issue: No ]

specific antibody determination

Original Primary Outcome Measures ^ICMJE

Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch

Change History

Complete list of historical versions of study NCT01191359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of the two administration routes with regard to safety aspects [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

adverse events

Original Secondary Outcome Measures ^ICMJE

Comparison of the two administration routes with regard to safety aspects

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Allergy

Intervention ^ICMJE

Biological: oral immunotherapy

orally applied specific immunotherapy

Other Name: SLITone birch

Study Arm (s)

Active Comparator: sublingual administration
oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose)

Intervention: Biological: oral immunotherapy
Active Comparator: vestibular administration
oral immunotherapy with drops applied by single dose containers (200 STU per dose)

Intervention: Biological: oral immunotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01191359

Other Study ID Numbers ^ICMJE

SP-B-02

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

ALK-Abelló A/S

Study Sponsor ^ICMJE

ALK-Abelló A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas Bieber, MD, PhD

Universitäsklinik Bonn, Dermatology

Information Provided By

ALK-Abelló A/S

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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