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: Allergic (IgE-mediated) rhinitis/rhinoconjunctivitis due to sensitization to grass pollen
MedDRA version: 12.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis
MedDRA version: 12.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollen
MedDRA version: 12.0Level: LLTClassification code 10053741Term: Allergenic desensitization procedure

Registration Number: EUCTR2009-015012-18-DE

Lead Sponsor: HAL Allergy BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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