PURETHAL Birch Rush study.

Conditions: Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
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: 16.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855

Registration Number: EUCTR2013-000086-36-PL

Lead Sponsor: HAL Allergy B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>;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<br>•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). <br>;Timepoint(s) of evaluation of this end point: The evaluation of the primary end points will be performed after the<br>end of the trial.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Early and late local reactions.<br>2.Systemic reactions within 24 hours.<br>3.Other adverse events recorded during the study.<br>4.Other safety variables.<br>5.Specific immunoglobulins.;Timepoint(s) of evaluation of this end point: The evaluation of the secondary end points will be performed after the<br>end of the trial.