Allergic (IgE-mediated) rhinitis/rhinoconjunctivitis due to sensitization to grass pollen MedDRA version: 12.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis MedDRA version: 12.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen MedDRA version: 12.0 Level: LLT Classification code 10053741 Term: Allergenic desensitization procedure
Conditions
Interventions
Trade Name: PURETHAL Gräser
Product Name: PURETHAL Gräser
Pharmaceutical Form: Suspension for injection
Sponsors
HAL Allergy BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years related to grass pollen, eligible for SCIT. Confirmation of IgE-mediated allergy by means of: • Positive SPT to grass pollen (mean wheal diameter = 3 mm (see appendix 2) and negative control truly negative (no reaction), or • Specific serum IgE-test (ssIgE >0.7 U/ml) for grass pollen, or • Positive provocation test for grass pollen. •Age = 18 years. •Patients have given a written informed consent. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Chronic asthma or emphysema, particularly with a FEV1 = 70% of predicted value. •Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV). •Active inflammation/infection of the target organs (nose, eyes, lungs). •Severe atopic dermatitis in need for systemic immunosuppressive medication. •Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension. •Severe kidney disease. •Diseases with a contra-indication for the use of adrenaline. •Treatment with systemic or local b-blockers or immunosuppressive drugs. •History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis. •Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months. •Participation in a clinical study with a new investigational drug within the last three months. •Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man). •Alcohol or drug abuse. •Lack of co-operation or severe psychological disorders. •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs. •Low compliance or inability to understand instructions/study documents. •Completed or ongoing treatment with anti-IgE-antibody. •Patients being in relationship or dependence with the sponsor or investigator. •Allergy to any of the excipients. •Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to show that reaching the maintenance dose of 0.5 ml PURETHAL Grasses following a rush initial phase of three injections (0.1, 0.3 and 0.5 ml) given in weekly intervals is as safe as a conventional initial phase of six injections (0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml) given in weekly intervals. Within the scope of this study an initial phase is considered safe if no possible injection related systemic side effect occurred during the first 24 hours after injection or, due to large local reactions, more than 2 additional injections are needed to reach the maintenance dose.;Secondary Objective: In addition local reactions and systemic reactions throughout the study will be assessed as secondary parameters. Furthermore, pharmacodynamic parameters of PURETHAL Grasses showing an effect on the immune system will be analysed by means of serum levels of allergen specific immunoglobulins (IgG and IgE).;Primary end point(s): The primary endpoint of the study is the comparison of the proportion of patients who have successfully reached the maintenance dose between the two treatment groups (rush vs. conventional). A patient is regarded as having successfully reached the maintenance dose in case he/she did not experience an at least possibly treatment related systemic reaction > grade I within 24 hours after the injection or he/she needed not more than 2 additional injections to reach the maintenance dose of 0.5 ml. This means that in the rush treated group the 5th injection must contain 0.5 ml and in the conventional treated group the 8th injection must contain 0.5 ml. In all other cases the patient will be regarded as not successfully reaching the maintenance dose. | — |
Countries
Germany
Outcome results
None listed