Allergic Rhinoconjunctivitis
Conditions
Brief summary
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.
Interventions
DRUGDepiquick Birch (DPG103)
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must experience significant allergic symptoms on visit 2 2. Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens 3. Specific IgE against birch allergens (CAP RAST ≥ 2)
Exclusion criteria
1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens 2. FEV1 or PEF value ≤ 80 % 3. Persistent asthma (GINA ≥ 2) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Symptom and Medication Score (SMS) | From the start of treatment until the end of the relevant pollen exposition time. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Symptom and Medication Score (SMS) | date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months | 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 |
| Onset of action (patient's assessment) | date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months | 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. |
| Rhinoconjunctivitis Quality of Life questionnaire (RQLQ) | Visits 2, 4, 6, and 7 | 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). |
Countries
Germany
Outcome results
None listed