A multicentre randomised Phase II clinical pilot study to compare the pharmacodynamic efficacy and tolerability of the sublingual and the vestibular administration route for SLITonePLUS® Birch
- Conditions
- Birch pollen induced allergic rhinoconjunctivitis requiring treatment during the birch pollen seasonMedDRA version: 12.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis
- Registration Number
- EUCTR2009-014580-39-DE
- Lead Sponsor
- ALK-Abelló Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Male and female patients 18-65 years who have given written informed consent, with the following main inclusion criteria:
• A clinical history of birch pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the birch pollen season
• Lack of adequate relief with symptomatic medication during the previous pollen season
• Positive Skin Prick Test (SPT) response to Betula verrucosa (wheal diameter = 3 mm) currently performed or not older than 60 days before screening
• Positive specific IgE against Betula verrucosa (IgE Class = 2).
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)
F.1.3.1 Number of subjects for this age range
• Uncontrolled or severe asthma (FEV1 < 70% of predicted value in spite of adequate pharmacologic treatment)
• History of emergency visit or admission for asthma in the previous12 months
• Previous treatment by immunotherapy with birch or tree pollen allergen within the previous 5 years
• Exclusion criteria in accordance with contraindications in the SmPC of SLITonePLUS.
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