Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

April 29, 2013 updated by: ALK-Abelló A/S

A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-10117
        • Charité Klinik für Dermatologie, Venerologie und Allergologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A history of birch pollen allergy
  • Positive skin prick test to birch
  • Positive conjunctival test to birch
  • Positive specific Immunoglobulin E (IgE) to birch

Exclusion Criteria:

  • Forced expiratory volume in 1 second (FEV1)<70% of predicted value
  • History of seasonal allergy interfering with study
  • History of symptomatic perennial allergy
  • History of emergency visit or admission for asthma in the previous 12 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sublingual immunotherapy
sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
Biological: Sublingual immunotherapy
once daily intake of sublingual drops
Other Names:
  • SLITone(TM) Birch
PLACEBO_COMPARATOR: Placebo
placebo sublingual drops
Biological: Placebo
once daily intake of sublingual drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Rhinoconjunctivitis Symptom Score
Time Frame: Birch pollen season 2006
A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Birch pollen season 2006
Daily Rhinoconjunctivitis Rescue Medication Score
Time Frame: Birch pollen season 2006
Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).
Birch pollen season 2006

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects
Time Frame: Birch pollen season 2006
The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).
Birch pollen season 2006
Adverse Events
Time Frame: Birch pollen season 2006
An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).
Birch pollen season 2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Margitta Worm, MD, Prof., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

August 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

April 2, 2006

First Submitted That Met QC Criteria

April 2, 2006

First Posted (ESTIMATE)

April 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2013

Last Update Submitted That Met QC Criteria

April 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • SHX0712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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