Allergic rhinitis and/or rhinoconjunctivitis with or without mild intermittent asthma caused by clinical relevant sensitisation against grass pollen AND birch pollen. MedDRA version: 9.1 Level: LLT Classification code 10039097 Term: Rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10039095 Term: Rhinitis seasonal
Conditions
Interventions
Product Name: Depigoid Grass / Birch Mix
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Prior to study specific examinations the patient and if, applicable, both legal guardians have to give his/her written informed consent. 2. Patients of both gender aged from 12 and 70 years. 3. Patient`s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS) 4. FEV1 of PEF > 80% of predicted normal value under normal conditions. 5. Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against grass AND birch pollen. The IgE mediated sensitization has to be verified by: - suggestive medical history, - specific IgE against grass AND birch pollen CAP RAST =2, - a positive skin prick test (SPT) or provocation test for grass pollen AND birch pollen (SPT resulting in a wheal diameter of at least 3 mm; the provocation test is deemed to be negative, if no reaction emerges in consequence to an application of a maximum concentration of 1/10 ). If both tests are performed, the result of the PT will be decisive. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease specific criteria 1. History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite) For clarification: According to the decision tree (see Appendix 3), patients with typical symptoms against the co-allergens, weed pollen, mould, house dust mite, cat and dog are not allowed to enter the trial. Patients without symptoms will enter the trial if they are not exposed to the allergen, even if CAP RAST is = 2. In case they are exposed to the allergen they must have a specific CAP RAST < 2 to be able to enter the trial. 2. Persistent asthma (GINA = II). Patients with other known concomitant diseases / treatments 3. Active tuberculosis. 4. Acute and chronic inflammatory or infectious diseases at the target organ. 5. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis). 6. Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases). 7. Immune deficiencies. 8. Uncontrolled asthma, defined as FEV1 or PEF = 80% of predicted normal value. 9. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism). 10. Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant. 11. Malignant disease of any kind during the previous 5 years. 12. Abnormal laboratory parameters and vital signs that could increase the risk to the study participant. 13. Alcohol, drug or medication abuse within the past year. 14. Severe psychiatric / psychological / neurological disorders. Patients with other known previous / concomitant treatments The following therapies are not allowed within the specified period prior to screening as well as during the study and will prevent the patient from being included into the study: 15. Participation in an immunotherapy against grass and/or birch pollen with comparable extracts within the last five years. 16. Local and systemical treatment with ß-blocker is not allowed during the entire study and will lead to the patient being withdrawn. 17. Treatment with substances interfering with the immune system are not allowed during the entire study and will lead to the patient being withdrawn. 18. Treatment with tranquilizer or psychoactive drugs. 19. Treatment with systemic corticosteroids within 3 months prior to the study. 20. An immunization with vaccines 7 days prior and 14 days post an injection. Others 21. Patients who are expected to be non-compliant and/or not co-operative. 22. Participation in any other clinical study within the last 30 days prior to the start of the study. 23. Patients who have already participated in this study. 24. Patients who are employees at the investigational site, relatives or spouses of the investigator. 25. Any donation of germ cells, blood, organs, or bone marrow during the course of the study. 26. Patients who are not contractually capable Special restrictions for female patients. 27. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation. 28. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of safety and efficacy of Depigoid® Grass / Birch Mix with Placebo during two birch pollen and grass pollen seasons in patients with allergic rhinitis and/or rhinoconjunctivitis with or without mild intermittent asthma caused by a clinical relevant sensitization against grass pollen AND birch pollen. ;Secondary Objective: • Symptom score • Medication score • Well days (symptom score = 2 and no rescue medication ) • Medication free days • Specific IgE, IgG4 • Quality of life (RQLQ/AdolRQLQ) • Health Status (EQ-5D) • Adverse events (type, frequency, severity) • Physician´s overall assessment • Patient´s overall assessment;Primary end point(s): Symptom load for rhinitis and/or rhinoconjunctivitis (hierarchically evaluated: after two seasons (1st step) / one season (2nd step) of treatment. | — |
Countries
Bulgaria, Germany, Lithuania
Outcome results
None listed