E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinitis against birch pollen |
|
MedDRA Classification |
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 |
To evaluate the efficacy and safety of SLIT compared with placebo for reduction of symptoms and rescue medication usage. Primary objective: is to assess the efficacy of an ultra-rush titrated SLIT
- on a Total Combined Score (TCS), taking into account a Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and
- on a Total Rescue Medication Score (TRMS, use of antihistamines, nasal corticosteroids and systemic corticosteroids)
for the peak of the birch pollen season. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: ---> To assess the efficacy of an ultra rush titrated SLIT on the - Six individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS) for the peak of the birch pollen season, - Global evaluation by the patient, the parents or the legal guardians of the patient for the total birch pollen season; ---> To document the safety of the treatment.
Exploratory objectives: ---> Total IgE and specific IgE (birch), ---> Evaluation of the primary objective for the total birch pollen season. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Female or male patients aged 6 - 14 with allergic rhinitis and/or allergic rhinoconjunctivitis
Clinical sensitisation to tree pollen (birch and possible alder and/or hazel) Sensitisation to further aeroallergens and to mites, cat and dog and further seasonal allergic rhinitis and seasonal mild or moderate allergic asthma are considered as not relevant
Positive clinical history of tree pollen (birch and possible alder and/or hazel), proven by: - the majority of clinical symptoms appearing duringthe appropriate season for birch pollen (and possible alder and/or hazel pollen season); - positive skin prick test (wheal diameter > 3 mm) and presence of specific IgE (positive CAP RAST class II and above); - planned antiallergic or antiasthmatic treatment with the following drugs: local Levocabastine (nose, eye) oral Cetirizine, nasal Fluticasone;
Total symptom score on the RRTSS during the previous pollen season of greater than or equal to 8
Compliant patient (respectively the parents or the legal guardians of the patient) being able to complete a diary card for self evaluation of the symptoms and antisymptomatic medication
Signed and dated Patient’s informed consent for patients aged 12 and older as well as an signed and dated informed consent by the parents or legal guardians
Safety laboratory results within the normal range or considered as not clinically significant. |
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E.4 | Principal exclusion criteria |
Previous immunotherapy with hazel pollen, alder pollen and/or birch pollen extracts within the last 3 years
Perennial allergic rhinitis
Perennial allergic asthma
Simultaneous participation in other clinical trials
Other reasons contra-indicating an inclusion into the trial according to the Investigator’s estimation (poor compliance)
Active tuberculosis
Auto - immune disorders
Severe chronic-inflammatory diseases
Malignancy
Irreversible secondary disorders at the target organ (emphysema, bronchoectasis)
Patients treated with b-blockers |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy available:
Total Combined Score (TCS), taking into account the RTSS and the TMRS. Evaluation will be done for the peak of the pollen season.
The Rhinoconjunctivitis Total Symptom Score (RTSS) is: Total symptom score (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) as daily evaluated by the patient, resp. the parents or the legal guardians of the patient, using the score from 0 to 3: 0 = absent symptoms (no sign / symptom evident) 1 = mild symptoms (sign / symptom clearly present, but minimal awareness, easily tolerated), 2 = moderate symptoms (definite awareness of sign / symptom that is bothersome, but tolerable), 3 = severe symptoms (sign / symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).
The Total Rescue Medication Score (TRMS) is: The TRMS is the product of the daily recorded intake of antisymptomatic drug and a evaluated factor according to the quality of the antisymptomatic drug. For the quality of antisymptomatic drug: Antihistamines 4.0 Corticosteroids (local) 4.0 Corticosteroids (systemic) 5.0
In terms of antihistamines there has to be considered equally: One unit of Cetirizine = 2 x 2 drops of Levocabastine (eye drops) plus 2 x 2 puffs Levocabastine (nasal spray) => factor 4. One drop each eye/day and one puff each nose/day => factor 2. |
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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 | 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 | Information not present in EudraCT |
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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
|
given in the protocol: chapter: V.1.; V.3.; VI.3.; VI.5. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |