IgE-mediated allergic disease manifested as symptoms of allergic rhinoconjunctivitis with or without controlled asthma caused by grass pollen. MedDRA version: 9.1 Level: LLT Classification code 10048908 Term: Seasonal allergy
Conditions
Interventions
Product Name: Solution of grass pollen allergen extract in a water/glycerol solution with phosphate buffered salin
Pharmaceutical Form: Oral drops, solution
Concentration unit: µg microgram(s)
Concent
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female outpatients •Age18 - 65 years •IgE-mediated seasonal allergic rhinoconjunctivitis with or without controlled asthma caused by grass pollen documented by •Positive skin prick test wheal for grass pollen > 5mm in diameter and •Positive histamine (0.1% histamine free base) wheal >3mm and a negative NaCl control reaction 1.5kU/L to grass pollens and •Proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and •Main discomfort in the months May, June, July of the year •For female patients with childbearing potential: (i.e., females are not chemically or surgically sterilised or females who are not post-menopausal) must have a negative serum pregnancy test before the baseline phase. •Female patients must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control (i.e., double barrier method, oral contraceptive, implant, dermal contraception, long-term inject able contraceptive, intrauterine device, or tubar ligation) during the study, as judged by the investigator. •Be able to understand and comply with the requirements of the study, as judged by the investigator •For patients with bronchial asthma at entry: confirmed diagnosis and asthma classification as controlled “according” GINA guidelines (version 2006). At the Beginning of the treatment phase: •Rhinoconjunctivitis symptoms documented in the patients diary during the baseline season •Patients must have demonstrated a Symptom - Score of at least 4 every day during the week following the peak pollen count in the baseline season. 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: •Previous or other current specific immunotherapy with grass pollen allergens in any formulation •For allergens which interfere with the grass pollen season: (Plantain, Nettle, Birch, Olive tree, Parietaria officinalis, Alternaria alternata, Cat epithelia, Dermatophagoides farinae, Dermatophagoides pteronyssinus): •Sensitisation in the Skin Prick Test: wheal diameter of respective interfering allergen = wheal diameter of grass pollen allergen •Previous course of hyposensitisation against grass pollen or other allergens that are not known •Patients who have undergone an unsuccessful course of specific immunotherapy with any allergen •Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons •PEF or FEV1 < 80% of predicted normal (ECCS) •Uncontrolled or partly controlled asthma according GINA guidelines (version 2006) •Febrile infections or inflammation of the respiratory tract at the time of inclusion •Severe acute or chronic diseases, severe inflammatory diseases (liver, kidneys, metabolic diseases) •Autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies •Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) •Treatment with beta-blockers (locally and systemically) •Recurrent seizures •Pregnancy and lactation period •Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days •Low compliance or inability to understand instructions/study documents •Involvement in the planning and conduct of the study (applies to both) Allergopharma Joachim Ganzer KG staff or staff at the study site. •Patients being in any relationship of dependence with the Sponsor and/or with the Investigator •Previous enrolment or randomisation of treatment in the present study •Completed or ongoing treatment with anti-IgE-Antibody •Completed or ongoing long-term treatment with tranquilizer psychoactive drugs •Allergy treatment according to severity of symptoms with other than the following medication during the grass pollen season: Levocabastine nasal spray/eye drops, Loratadine/Cetirizin tablets, Salbutamol and exacerbation treatment with a short course of oral corticosteroids. •Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint of this study is difference between active treatment and placebo in the change of the Area Under the Curve of the Symptom - Medication - Score (SMS) from the baseline season to the season after 1 year of treatment. The SMS will be calculated by the daily sum of symptoms and use of anti-allergic medication documented in patients’ diaries during the pollen season.;Main Objective: Demonstrating safety and efficacy of a sublingual administration of grass pollen allergen in patients with allergic rhinitis (due to grass pollen allergy) with or without asthma. Measurement includes symptom-medication-score between IMP and placebo group, respectively between baseline pollen season and first pollen season. ;Secondary Objective: Efficacy in terms of immunologic blood parameters: allergen-specific IgE, IgG1 and IgG4, measured at start and end of IMP-season. Long-term efficacy, measured by change in symptom-medication-score after two, respectively three years of treatment with IMP. | — |
Countries
Germany, Italy
Outcome results
None listed