Allergic rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: Oralgen® Grass Pollen
Pharmaceutical Form: Oral drops, solution
Other descriptive name: Phleum pratense
Concentration type: equal
Concentration number: 1,900 BU/ml-
Other descriptive nam
Sponsors
Artu Biologicals Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who successfully completed study AB0602 up to visit 10. 2. Patients who have been informed of the nature and aims of the study and have given their written consent / assent to participate in this study in accordance with local laws and requirements. 3. Patients who are willing to comply with the protocol and understand the information given and the text of the consent form. 4. Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method (for example, hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with male condom, bilateral tubal ligation, diaphragm used with spermicide, female condom, monogamous relationship with vasectomised partner). 5. Negative urine pregnancy test if female at visit 10 of the previous study. 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: 1. For patients meeting any of the exclusion criteria of study AB0602, the sponsor needs to be consulted before inclusion. 2. Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method. 3. Patients who were non-compliant during study AB0602. 4. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy after 2 years treatment of three dose regimens of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis.;Secondary Objective: To assess long-term safety and tolerability of three dose regimens of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis.;Primary end point(s): Rhinoconjunctivitis Total Symptom Score The severity of the seven symptoms of rhinoconjunctivitis during the previous 24 hours is to be scored every day between 20:00 and 22:00 on a 4 point scale (from zero to three). The individual scores are to be entered on the patient diary from Visit 4 to the Follow up Visit. The Rhinoconjunctivitis Total Symptom Score (RTSS), Pollen Season RTSS and Diarised Period RTSS will be calculated. Diarised Period: The Diarised Period is defined as the period from Visit 4 up to the last dose at the end of the centre-specific pollen season. The change from the score on the RRTSS to the RTSS will be calculated. The severity of the seven rhinoconjunctivitis symptoms are rated on a 4-point descriptor scale as follows: 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 hard to tolerate; causes interference with activities of daily living and / or sleeping) | — |
Countries
Czech Republic, Germany, Hungary, Lithuania, Netherlands, Slovakia
Outcome results
None listed