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

• Conditions: Rhinitis and/or rhinoconjunctivitis with or without allergic asthma caused by clinical relevant sensitization against tree pollen.; MedDRA version: 8.1Level: LLTClassification code 10039083Term: Rhinitis

• Registration Number: EUCTR2006-003067-31-LT
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-08
• Last Update Posted: 19 March 2012

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

1.Pregnant or lactating women
2.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose
partners have been sterilized by vasectomy or other means, unless they meet
the following definition of postmenopausal: 12 months of natural (spontaneous)
amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >
40 mIU/mL or are using one or more of the following acceptable methods of
contraception:
a) surgical sterilization (e.g., bilateral tubal ligation, hysterectomy)
b) hormonal contraception (implantable, patch, oral)
c) double-barrier methods (any double combination of: IUD, male or female
condom with spermicidal gel, diaphragm, sponge, cervical cap)
Acceptable methods of contraception may include total abstinence at the
discretion of the investigator in cases where the age, career, lifestyle, or sexual
orientation of the patient ensures compliance. Periodic abstinence (e.g.,
calendar, ovulation, symptothermal, postovulation methods) and withdrawal are
not acceptable methods of contraception. Reliable contraception should be
maintained throughout the study and for 30 days after study drug
discontinuation.

3.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
4.Participation in an immunotherapy with comparable extracts within the last five years
5.Participation in another clinical trial within the last 3 months prior to this study
6.Smokers with a manifested bronchopathy
7.Alcohol or drug abusers
8.Persons, who are obviously not compliant
9.Patients, who are employees at the investigational site, relative or spouse of the investigator

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified