A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- systemic reactions > grade I or large local reactions related to injection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
conventional regimen of PURETHAL Grasses
Initial treatment:
6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml (week 1, 2, 3, 4, 5, 6).
Maintenance treatment:
0.5 ml in intervals according to registered scheme (week 8, 10, 12, 16).
干预措施: PURETHAL Grasses, 20.000 AUM/ml (Drug)
rush regimen of PURETHAL Grasses
Initial treatment:
3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml (week 1, 2, 3)
Maintenance treatment:
3 monthly doses of 0.5 ml (week 7, 11, 15).
干预措施: PURETHAL Grasses, 20.000 AUM/ml (Drug)
结局指标
主要结局
systemic reactions > grade I or large local reactions related to injection
时间窗: 24 hrs after injection
次要结局
- specific serum IgE and IgG concentrations(16 weeks)