Birch pollen induced allergic rhinoconjunctivitis requiring treatment during the birch pollen season MedDRA version: 12.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: SLITonePLUS
Pharmaceutical Form: Oromucosal solution
Sponsors
ALK-Abelló Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the trial are: To demonstrate non-inferiority of vestibular administration of SLITonePLUS (Group V) compared to the sublingual administration (Group S) with regard to changes from baseline in spec. IgE-blocking factor against Betula verrucosa after 36 (in hierarchical order: 24, 12, 8, 4) weeks of treatment (a = 0.025 one-tailed, non-inferiority margin d = -0.075). The study outcome will be classified as successful if a significant non-inferiority is demonstrated on step 1 (week 36) of the ordered test. IN CASE OF SUCCESSFUL STUDY OUTCOME, tests of superiority of Group V vs. Group S will be carried out at each control visit (a = 0.025 one-tailed).;Secondary Objective: Secondary objectives are: To compare both administration routes after 4, 8, 12, 24, and 36 weeks of treatment with regard to changes from baseline in spec. IgG4 against Betula verrucosa in a repeated measurement design with baseline as covariate (logarithmically transformed data). To compare both administration routes after 4, 8, 12, 24, and 36 weeks of treatment with regard to changes from baseline in spec. IgE against Betula verrucosa in a repeated measurement design with baseline as covariate (logarithmically transformed data). To compare both administration routes with regard to the incidences of the following local reactions: oral pruritus, oedema mouth, oropharyngeal swelling, pharyngeal oedema, swollen tongue, glossodynia. Clinical;Primary end point(s): Immunological changes from baseline in spec. IgE-blocking factor against Betula verrucosa after 36, (24, 12, 8, 4) weeks of treatment with SLITonePLUS. | — |
Countries
Germany
Outcome results
None listed