Allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class
Conditions
Interventions
Product Name: Depiquick® Birch
Product Code: Depiquick® Birch 1000 DPP/mL
Pharmaceutical Form: Solution for injection
Current Sponsor code: Depiquick® Birke
Other descriptive name: Birch allergen extr
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. For adolescents (= 12 and =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites). Patients are not allowed to enter the study: - with typical symptoms against co-allergens such as grass/weed pollen, house dust mites, cat and dog - with CAP-RAST co allergen = birch (not applicable if negative provocation test for co-allergen not older than 12 months is available) 2. FEV1 or PEF value = 80% of the predicted normal value (for PEF: highest result of 3 measurements) 3. Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines 4. Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis and nasal polyposis 5. Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis) 6. Diseases of the immune system including autoimmune and immune deficiencies 7. Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism) 8. Severe uncontrolled diseases that could increase the risk for the patients participating in the study, which include but are not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or hematological disorders 9. Any malignant disease during the previous 5 years 10. Any significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk for the study patient 11. Alcohol, drug, or medication abuse within the past year 12. Severe psychiatric, psychological, or neurological disorders 13. Use of immunotherapy against birch or tree pollen within the last 5 years 14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer 15. Topical and systemic treatment with ß-blockers 16. Treatment with substances interfering with the immune system within 1 week prior to Visit 2 17. Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1 18. Use of systemic corticosteroids within 4 weeks prior to Visit 1 19. Immunization with vaccines within 7 days prior to Visit 2 20. Any condition which could interfere with the study objectives 21. Patients with hypersensitivity to excipients (see Section 6.2) of the investigational medicinal product 22. Patients expected to be non-compliant and/or not co-operative 23. Patients who have already participated in this study 24. Patients who are employees of the institution, or 1st grade relatives, or partners of the investigator 25. Women ¦ who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test. ¦ who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (urine) for all women and for girlsentering menarche is required with sufficient lead time before inclusion 26. Persons who are jurisdictionally or governmentally institutionalized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - SMS for rhinitis/rhinoconjunctivitis on the basis of all days with a certain median symptom score - Onset of action of intraseasonal specific short-term immunotherapy - Symptom score on the basis of the primary tree pollen exposition time - Symptom score on the basis of all days with a certain median symptom score - Medication score on the basis of the primary tree pollen exposition time - Medication score on the basis of all days with a certain median symptom score - Medication score by patients’ assessment - Health-related quality of life - Percentage of well days - Global evaluation of efficacy and tolerability;Primary end point(s): - combined symptom and rescue medication score (SMS) over the primary exposition time;Timepoint(s) of evaluation of this end point: - daily during primary exposition time ;Main Objective: To demonstrate superiority of Depiquick® Birch (1,000 DPP/mL) over Depiquick®-matching placebo (0 DPP/mL) with regard to efficacy of intraseasonal SIT as assessed by the combined symptom and medication score (SMS) for rhinitis/rhinoconjunctivitis on the basis of the primary tree pollen exposition time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - combined symptom and rescue medication score (SMS) over the secondary exposition time - quality of life ;Timepoint(s) of evaluation of this end point: - daily during secondary exposition time - visit 2, 4, 6, 7 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed