This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
202
Combined Symptom and Medication Score (SMS)
The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.
Time frame: From the start of treatment until the end of the relevant pollen exposition time.
Combined Symptom and Medication Score (SMS)
The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The overall severity rhinitis/rhinoconjunctivitis (including nasal itching, sneezing, rhinorrhea, nasal obstruction, ocular itching/grittiness/redness, and ocular tearing) and asthma (including chest tightness, shortness of breath, cough, wheezing) will be evaluated by the patient daily
Time frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Onset of action (patient's assessment)
Patients will document the point in time when they experience onset of action of the therapy by answering the question "Do you have the feeling that your allergy symptoms are better or less due to SIT today?" with "Yes" or "No".
Time frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)
The RQLQ is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinitis/rhinoconjunctivitis (Juniper and Guyatt 1991). It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions).
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Novartis Investigative Site
Aachen, Germany
Novartis Investigative Site
Aschaffenburg, Germany
Novartis Investigative Site
Augsburg, Germany
Novartis Investigative Site
Bad Wildbad, Germany
Novartis Investigative Site
Bad Wörishofen, Germany
Novartis Investigative Site
Bensheim, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bochum, Germany
...and 25 more locations
Time frame: Visits 2, 4, 6, and 7