Randomised, double blinded, placebo controlled, parallel group study toevaluate efficacy and safety of Depigoid® Grass / Birch Mix in patients withallergic rhinitis and/or rhinoconjunctivitis with or without mild intermittentasthma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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