PURETHAL Grasses Rush Study

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).

The primary parameter will be the proportion of patients who experience systemic reactions > grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.

It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HAL Allergy

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 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

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 beta-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.