PURETHAL is indicated for specific immunotherapy (desensitisation) of IgE-mediated, inhaled allergy with symptoms of allergic rhinitis, allergic conjunctivitis and allergic bronchial asthma with an allergic background. MedDRA version: 16.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Trade Name: PURETHAL single allergoids of pollen, 20,000 AUM/ml, suspension for injection
Product Name: PURETHAL single allergoids of pollen, 20,000 AUM/ml, suspension for injection
Pharmaceutical For
Sponsors
HAL Allergy B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent. 2.Age =12 years. 3.Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma 4.FEV1>70% for patients with a history of mild to moderate asthma, FEV1>70% or PEF>80% for patients without a history of asthma 5.A positive SPT (mean wheal diameter = 3mm compared to negative control and negative control should be negative) for birch pollen. 6.Positive serum specific anti-birch IgE-test (>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1.Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years 2.Any specific immunotherapy (SCIT or SLIT) during the study period 3.Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs 4.Active malignancies or any malignant disease within the past 5 years 5.Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders 6.Acute/active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study 7.Secondary changes of the target organ (emphysema, bronchi-ectasia and others) 8.Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma) 9.Use of systemic steroids within 4 weeks before start of the study and during the study 10.Treatment with systemic and local ß-blockers 11.Vaccination within one week before start of therapy or during the initiation phase 12.Anti-IgE therapy within the 6 months prior to inclusion and during the study 13.Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study 14.Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device in combination with a spermicide or –pill) 15.Alcohol, drug or medication abuse within the past year 16.Any clinically significant abnormal laboratory parameter at screening 17.Lack or expected lack of cooperation or compliance 18.Severe psychiatric, psychological, or neurological disorders 19.Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator
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 Birch following a rush regimen of three injections in weekly intervals is as safe as a conventional regimen of six injections in weekly intervals. ;Secondary Objective: •Safety and tolerability of the rush regimen compared to the conventional regimen assessed by early (within 30 minutes after injection) and late local and systemic reactions •Short-term pharmacodynamic effect of the rush regimen compared to the conventional regimen assessed by means of serum levels of allergen specific immunoglobulins (IgG and IgE);Primary end point(s): The primary endpoint of the study is comparison of the proportions of patients who have successfully reached the maintenance dose between the two treatment regimens (rush vs. conventional). ;Timepoint(s) of evaluation of this end point: The evaluation of the primary end points will be performed after the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Early and late local reactions. 2.Systemic reactions within 24 hours. 3.Other adverse events recorded during the study. 4.Other safety variables. 5.Specific immunoglobulins.;Timepoint(s) of evaluation of this end point: The evaluation of the secondary end points will be performed after the end of the trial. | — |
Countries
Poland
Contacts
Public ContactClinical Trial Manager
HAL Allergy B.V.
Outcome results
None listed