E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Birch pollen allergic Rhinoconjunctivitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066093 |
E.1.2 | Term | Birch pollen allergy |
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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 main objective of the trial is to assess the sustained clinical efficacy on the Average Adjusted Symptom Score (AAdSS): a score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and daily rescue medication usage of a 300 IR dose of a birch pollen allergen extract sublingual solution, administered once daily during 5 months per year, after 2 consecutive years in patients with birch pollen allergy. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of a 300 IR daily dose of a birch pollen allergen extract sublingual solution on the: - Average Adjusted Symptom Score (AAdSS) on non-primary efficacy analysis sets and/or other evaluation periods - Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms: sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes - Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or/and eye drops], nasal corticosteroid and oral corticosteroid) - Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS) - Average Combined Score (ACS): A score taking into account the RTSS and the RMS - Intensity of Rhinoconjunctivitis symptoms using a Visual Analogue Scale (RVAS) - The proportion of controlled patients with 25%, 50% or 75% of symptom-controlled days over the pollen period And to document the safety of the treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The main inclusion criteria are: - Male or female outpatients aged 18 to 65 years (inclusive). - Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
- Sensitization to birch pollen demonstrated by: •A positive SPT to birch pollen with wheal diameter > 3 mm. •Birch pollen allergens specific IgE levels ≥ 0.70 kU/L. - RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18. - Patients with an FEV1 ≥ 80% of the predicted value. - Patients who are willing to comply with the protocol. - Patients having given a signed informed consent before completing any study related procedure.
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E.4 | Principal exclusion criteria |
Exclusion Criteria: -Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study. -Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years. -Patients with ongoing treatment by immunotherapy with another allergen. -Pregnancy (positive pregnancy test), breast-feeding. -Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner). - Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days). - Patients with moderate or severe persistent asthma (GINA 3 or 4). - Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents. - Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation). - Patients with severe immune deficiency. - Patients with a past or current disease, which as judged by the Investigator, may affect the patient’s participation in or outcome of this study. - Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator’s opinion). - Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs. - Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening). - Patients under continuous corticotherapy (inhaled or systemic drugs). - Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution. - Investigators, co-Investigators, as well as their children or spouses and all study collaborators. - Patients who have participated in any clinical trial within 3 months prior to this one.
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E.5 End points |
E.5.1 | Primary end point(s) |
The AAdSS while on treatment during the second pollen period is the primary efficacy endpoint for the sustained clinical efficacy. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 79 |
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 | Yes |
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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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |