E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Birch pollen induced allergic rhinoconjunctivitis requiring treatment during the birch pollen season |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 (α = 0.025 one-tailed, non-inferiority margin δ = -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 (α = 0.025 one-tailed). |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Two different administrations routes of the same IMP |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Follow-up contact 1 week after the last drug intake |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |