A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid® tree polle

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

1.Patients of both gender aged from 18 up to 65 years
2.Prior to study specific examinations the patient has to give his/her written informed consent
3.Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
4.FEV1 or PEF > 70% of predicted normal value under normal conditions
5.The patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitization against tree pollen. The IgE mediated sensitization has to be verified by
·Suggestive medical history
·A positive skin prick test LETI for tree pollen, resulting in a wheal diameter of at least 3 mm > negative control reaction or '++' versus histamine
·Specific IgE >=1 (CAP-RAST)

Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

6.Pregnant or lactating women
7.Women of child bearing age not employing sufficient contraceptive protection (contraceptive medication or condom)
8.Clinical relevant manifestation -defined as positive suggestive history within the last 12 months checked by a comprehensive questionnaire of symptoms, confirmed by a positive skin prick test (wheal diameter of at least 3 mm > negative control reaction or '++' versus histamine) as well as by specific IgE (RAST I or higher) -of the following allergies:
·A perennial allergy against house dust mites (Dermatophagoides pteronyssinus or D. farinae), animal epithelia (of cats or dogs) or mould
·A seasonal allergy against grasses (included rye) or weeds
9.Participation in an immunotherapy with comparable extracts within the last five years
10.Participation in another clinical trial within the last 3 months prior to this study
11.Smokers with a manifested bronchopathy
12.Alcohol or drug abusers
13.Persons, who are obviously not compliant
14.Patients, who are employees at the investigational site, relative or spouse of the investigator

Patients with other known concomitant diseases:
15.Acute tuberculosis
16.Acute and chronic inflammatory or infectious diseases (incl. target organ)
17.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
18.Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
19.Immune deficiencies
20.Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value
21.Treatment with b-blockers
22.Malignancies < 5 years
23.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
24.Serious psychiatric/psychological disturbances
25.Concomitant treatment with substances interfering with the immune system

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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