Allergic rhinitis against birch pollen
Conditions
Interventions
Trade Name: Staloral Birke 300 IR/ml
Product Name: Staloral Birke
Product Code: PEI.H.03013.03.1
Pharmaceutical Form: Sublingual spray
Pharmaceutical form of the placebo: Sublingual spray
Route of adm
Sponsors
Stallergenes GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;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 s | — |
Countries
Germany
Outcome results
None listed