Allergic Rhinoconjunctivitis
Conditions
Keywords
randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, Allergy, Rhinoconjunctivitis, Immunotherapy, Grass pollen extract
Brief summary
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
Detailed description
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
Interventions
DRUGOralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Patients will receive matching placebo sublingually
Sponsors
Artu Biologicals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* male or female aged 18-50 * patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons * Positive skin prick test and IgE value of at least Class 2+ * RTSS of greater or equal to 14 during pollen season prior tot the start of the study * Patients must be in general good health * Patients with normal spirometry * Informed consent given and willing to comply with the protocol * Female patients are eligible if they use an accepted contraceptive method * Negative urine pregnancy test if female
Exclusion criteria
* Pregnancy, breast feeding * Asthma requiring treatment other than beta-2 inhaled agonists * patients who have taken oral steroids within 12 weeks before screening visit * patients who have received desensitisation treatment for grass pollen * treatment by immunotherapy with any other allergen within the previous 5 years * patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit * patients at risk of non-compliance * participation in any other clinical study within the previous 3 months * patients with a past or current disease, which may affect participation in or outcome of this study. * patients treated with beta-blockers or under continuous corticotherapy * allergic sensitivity to epithelial allergens the patients is exposed to * positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period * intention to subject the patient to surgery of the nasal cavity during current study * Usual contraindications of immunotherapy * a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) | One year |
Secondary
| Measure | Time frame |
|---|---|
| Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests. | one year |
Countries
Bulgaria, Czechia, Germany, Hungary, Lithuania, Netherlands, Slovakia
Outcome results
None listed