Birch pollen allergic Rhinoconjunctivitis MedDRA version: 14.0 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: STALORAL Birch 10 I.R./ml
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Birch Pollen Allergen Extract
CAS Number: 8000045252
Other descriptive name: ALLERGENS, POLLEN & PL
Sponsors
Stallergenes S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 544 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ARTSS during the evaluation periods while the patient is on treatment. ARMS during the evaluation periods while the patient is on treatment. ARSS during the evaluation periods while the patient is on treatment. ACS during the evaluation periods while the patient is on treatment.;Timepoint(s) of evaluation of this end point: end of study, after two years of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The Average Adjusted Symptom Score AAdSS on non-primary efficacy analysis sets and/or other evaluation periods. The Average Adjusted Symptom Score AAdSS in three subgroups of pooled sites grouped according to the mean AAdSS in the placebo group (AAdSS by tertiles).The Average Rhinoconjunctivitis Total Symptom Score ARTSS of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes The Average Rescue Medication Score ARMS and use of rescue medication Each of the six individual Average Rhinoconjunctivitis Symptom Scores ARSS. The Average Combined Score ACS: A score taking into account the Rhinoconjunctivitis Total Symptom Score RTSS and the Rescue Medication Score RMS The intensity of Rhinoconjunctivitis symptoms using a Visual Analogue Scale RVAS score The standardized Rhinoconjunctivitis Quality of Life Questionnaire score RQLQ(S) The Proportion of Symptom-Controlled Days (PSCDs) To document the safety of the treatment;Primary end point(s): The Average Adjusted Symptom Score (AAdSS) while on treatment during the second pollen period is the primary efficacy endpoint for the sustained clinical efficacy.;Timepoint(s) of evaluation of this end point: end of study, after two years of treatment | — |
Countries
Czech Republic, Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Sweden
Contacts
Public ContactMedical Department
Stallergenes SA
Outcome results
None listed