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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004185-14 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depiquick® Birch | Experimental | At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. |
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| Placebo | Placebo Comparator | At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depiquick Birch (DPG103) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of treatment until the end of the relevant pollen exposition time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Aachen | 52074 | Germany | |||
| Novartis Investigative Site |
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| 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". | 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). | Visits 2, 4, 6, and 7 |
| Aschaffenburg |
| 63739 |
| Germany |
| Novartis Investigative Site | Augsburg | 86179 | Germany |
| Novartis Investigative Site | Bad Wildbad | 75323 | Germany |
| Novartis Investigative Site | Bad Wörishofen | 86825 | Germany |
| Novartis Investigative Site | Bensheim | 64625 | Germany |
| Novartis Investigative Site | Berlin | 13057 | Germany |
| Novartis Investigative Site | Berlin | 13187 | Germany |
| Novartis Investigative Site | Berlin | 14050 | Germany |
| Novartis Investigative Site | Bochum | 44803 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Chemnitz | 09130 | Germany |
| Novartis Investigative Site | Delitzsch | 04509 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Duisburg | 47051 | Germany |
| Novartis Investigative Site | Dülmen | 48249 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Gera | 07548 | Germany |
| Novartis Investigative Site | Hanover | 30159 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Leipzig | 04275 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Lübeck | 23538 | Germany |
| Novartis Investigative Site | Münster | 48143 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Neunkirchen | 66538 | Germany |
| Novartis Investigative Site | Nidderau | 61130 | Germany |
| Novartis Investigative Site | Oberhausen | 46145 | Germany |
| Novartis Investigative Site | Osnabrück | 49074 | Germany |
| Novartis Investigative Site | Rodgau | 63110 | Germany |
| Novartis Investigative Site | Wallenhorst | 49134 | Germany |
| Novartis Investigative Site | Wiesbaden | 64191 | Germany |
| Novartis Investigative Site | Wiesbaden | 65183 | Germany |
| Novartis Investigative Site | Witten | 58452 | Germany |