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

Study Overview
=================
Brief Summary
-----------------
The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

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

Official Title
-----------------
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

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: Sublingual immunotherapy
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sublingual immunotherapy<br>sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose) | Biological: Sublingual immunotherapy<br>* once daily intake of sublingual drops<br>* Other names: SLITone(TM) Birch;|
| Placebo Comparator: Placebo<br>placebo sublingual drops | Biological: Placebo<br>* once daily intake of sublingual drops<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Rhinoconjunctivitis Symptom Score | 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 | 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 | 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 | 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 |