A randomised, double blinded, placebo controlled multicentre study for the efficacy and safety of Depigoid birch pollen - N/A
- Conditions
- Patients have to suffer from IgE mediated allergic rhinits, rhinoconjunctivitis +/- asthma due to sensitization again birch pollen.MedDRA version: 7.0Level: LLTClassification code 10036019
- Registration Number
- EUCTR2004-001538-18-SE
- Lead Sponsor
- ETI Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
- Patients of both gender at an age from 6 up to 45 years
- Prior to study specific examinations, the patient has to give his/her written informed consent. If patients under legal age will be included, the informed consent must be signed by at least one of the parents or the legal responsible guardian.
- The patients have to suffer from seasonal complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitisation
against birch pollen. The sensitisation against birch pollen has to be verified by
- suggestive medical history
- a positive skin prick test for birch pollen, resulting in a wheal diameter of at
least 4 mm > negative control reaction or '++' versus histamine
- specific IgE for birch pollen >= 2
- Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
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) no
F.1.3.1 Number of subjects for this age range
- pregnant or lactating women
- women of child-bearing age not employing sufficient contraceptive protection
- 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 4 mm > negative control reac-tion 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
- participation in an immunotherapy with comparable extracts within the last five years
- participation in another clinical trial within the last 3 month prior to this study
- any contra-indication for the unspecific bronchial challenge test
- smokers with a manifested bronchopathy
- alcohol- or drug abusers
- persons, who are obviously not compliant
- patients with other known concomitant diseases:
- acute tuberculosis
- inflammatory or infectious diseases of the target organs effective
- advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
- immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- immune deficiencies
- history of status asthmaticus, heart- and vascular insufficiency, treatment with beta-blockers
- any disease which prohibits the use of adrenaline (e. g. hyperthyroidism)
- serious psychiatric / psychological disturbances
- 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