The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy
Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
226
once daily intake of sublingual drops
once daily intake of sublingual drops
Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, State of Berlin, Germany
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.
Time frame: 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).
Time frame: Birch pollen season 2006
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).
Time frame: 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).
Time frame: Birch pollen season 2006
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