Birch pollen rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: recombinant Bet v 1
Pharmaceutical Form: Sublingual tablet
Current Sponsor code: rBet v1
Other descriptive name: recombinant Bet v 1 allergen
Concentration unit: µg microgram(s)
Concentr
Sponsors
Stallergenes S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are to be verified at Visit 1 (Screening) and reviewed at Visit 2 (Randomisation). Patients must meet all of the following inclusion criteria in order to participate in this study: 1.Male or female outpatients aged 18 to 65 years (inclusive). 2.Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. 3.Sensitisation to birch pollen as demonstrated, at screening, by: -A positive SPT to birch pollen with wheal diameter greater than 3 mm. -Specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1). 4.Patients asymptomatic to all other allergens during the birch pollen season. 5.RRTSS during the previous pollen season = 12 out of a maximum possible score of 18. 6.Patients with an FEV1 = 80% of the predicted value. 7.Female patients with no childbearing potential. Female patients are considered not to have childbearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy, bilateral oophorectomy or ovariectomy. 8.Female patients of childbearing potential are eligible if they are not sexually active or if they: -Use 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), and -Have a negative urine pregnancy test, and -Are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study. 9.Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products. 10.Patients having provided signed informed consent before performing any study-related procedures. 11.Patients willing to comply with the protocol. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: The exclusion criteria are to be verified at Visit 1 (Screening) and reviewed at Visit 2 (Randomisation). Patients must not meet any of the following exclusion criteria in order to participate in this study: 1.Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method. 2.Patients with a history of drug or alcohol abuse. 3.Patients who have participated in any clinical trial within 3 months prior to this one. 4.Patients at risk of non-compliance. 5.Patients planning to move during the study. 6.Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study. 7.Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens. 8.Patients with symptomatic allergic rhinitis / rhinoconjunctivitis due to house dust mites. 9.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. 10.Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. (for example B. corylus [hazel], B. alnus [alder]) within the previous 10 years. 11.Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study). 12.Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polypsis or oral inflammation). 13.Patients with severe immune deficiency. 14.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. These diseases include, but are not limited to: -cardiovascular disease - malignancy-hepatic disease-immunological disease -renal disease or impairment-auto-immune disease-haematological disease-intercurrent infectious disease-neurological disease-endocrine disease 15.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). 16.Known hypersensitivity to mannitol. 17.Usual contra-indications of immunotherapy such as: -Concomitant local or systemic beta-blocker therapy and/or -Immunosuppressive drugs. 18.Patients with ongoing treatment by immunotherapy with another allergen. 19.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). 20.Patients under continuous corticotherapy. 21.Patients undergoing chronic treatment with H2-antihistamine drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of three doses of recombinant Bet v 1 (rBet v 1) administered as sublingual immunotherapy (SLIT) on: -The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use. ;Secondary Objective: To assess the efficacy of three doses of rBet v 1 administered as SLIT on: -The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). -The Average Rescue Medication Score (ARMS). -The rescue medication usage (use of H1-antihistamine drugs [oral form and/or eye drops], nasal corticosteroids or systemic corticosteroids). -The Average Combined Score (ACS) – a score taking into account the daily Rhinoconjuctivitis Total Symptom Score (RTSS) and the daily Rescue Medication Score (RMS). -Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS) (sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). -The proportion of symptom-controlled days (PSCD). -The proportion of valid ASS days during the pollen period while on treatment. -Global evaluation of the efficacy of SLIT by the patient. ;Primary end point(s): Primary Efficacy Variable: The AASS is an average of the adjusted RTSS based on the patient's rescue medication usage. It will be patient specific, but will take into account that patients were allowed to make use of any of three categories of rescue medication. Adjusted Symptom Score (ASS) is derived as follows: -ASS and RTSS are equal the first day of the pollen period: ASS1 = RTSS1 -If a patient did not take rescue medication at days (d-1) and (d) then: ASSd = RTSSd -If a patient took rescue medication at day (d) then: ASSd = max (RTSSd, ASSd-1) ASSd+1 = max (RTSSd+1, ASSd) -If RTSS is missing, then the information on the rescue medication intake is invalidate | — |
Countries
Finland, France, Germany, Lithuania, Sweden
Outcome results
None listed