EUCTR2009-015012-18-DEActive, not recruitingNot Applicable
A prospective, randomized, open, multi-centre study to assess safety of PURETHAL Grasses given with a rush induction schedule to patients with allergic rhinoconjunctivitis. - PURETHAL Grasses Rush study
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- HAL Allergy BV
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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