EUCTR2020-000455-12-LT进行中（未招募）1 期
A randomised, parallel-group, double-blind, placebo-controlled phase III trial assessing the efficacy and safety of 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis - SU-G-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •I1. Written informed consent obtained before any trial related procedures are performed
- •I2. Male or female aged =18 years on the day informed consent is obtained
- •I3. For female subjects of childbearing potential, a negative pregnancy test and willingness to practice appropriate contraceptive methods until the follow-up visit must be confirmed
- •I4. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
- •I5. A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
- •I6. Positive specific immunoglobulin E (IgE) (defined as =class 2, =0.70 kU/l) against grass: Phleum pratense
- •I7. Positive skin prick test (SPT) to Phleum pratense at screening
- •I8. The subject must be willing and able to comply with the trial protocol
- •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 440
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •E1. Previous participation in this trial. Participation is defined as screening
- •E2. Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
- •E3. Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- •E4. Reduced lung function: FEV1 <70% of predicted value after adequate pharmacologic treatment
- •E5. SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
- •E6. SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
- •E7. Ongoing treatment with any allergy immunotherapy product
- •E8. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening
- •E9. Severe chronic oral inflammation
- •E10. Any nasal or naso/oropharyngeal condition that could confound the efficacy or safety assessments (e.g. hypertrophy of the pharyngeal/palatine tonsils, clinically relevant nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinates)
- •E11. Has a diagnosis of eosinophilic oesophagitis
- •E12. At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
- •E13. A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
- •E14. Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
- •E15. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance
- •E16. Immunosuppressive treatment (ATC code L04 or L01) = 90 days prior to the screening visit
- •E17. Treatment with medications with potential impact on efficacy endpoints (e.g. treatment with anti-IgE drugs within 130 days/5 half-lives of the drug (which ever longest) or treatment with antidepressant or antipsychotic medications with antihistaminic effect)
- •E18. A history of allergy, hypersensitivity or intolerance to the IMP (except to the active ingredient) or any of the background treatment provided in this trial
- •E19. Female who is pregnant or breast-feeding
- •E20. Has a business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
研究者
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