NCT00901914已完成2 期
A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 16
- 主要终点
- Average Adjusted Symptom Score
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons
- •Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1)
- •Patients asymptomatic to all other allergens during the birch pollen season
- •RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
- •Patients with an FEV1 ≥ 80% of the predicted value
- •Female patients with no childbearing potential
- •Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method and have a negative urine pregnancy test, and are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study
- •Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products
- •Patients having provided signed informed consent
排除标准
- •Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
- •Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
- •Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study
- •Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. within the previous 10 years
- •Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study)
- •Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polyposis or oral inflammation)
- •Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or outcome of this study
- •Any disease or condition which would place a patient at undue risk by being included in the study (according to the investigator's opinion)
- •Usual contra-indications of immunotherapy such as concomitant local or systemic beta-blocker therapy and/or immunosuppressive drugs
- •Patients with ongoing treatment by immunotherapy with another allergen
- •Patients treated with inhaled/systemic steroids within 4 weeks prior to Screening, or with long acting systemic corticosteroids 12 weeks before Screening
- •Patients under continuous corticotherapy or undergoing chronic treatment with H2-antihistamine drugs
- •Known hypersensitivity to mannitol
- •Pregnancy, breast-feeding/lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method
- •Patients with a history of drug or alcohol abuse
结局指标
主要结局
Average Adjusted Symptom Score
时间窗: ~1 month (whole birch pollen season)
次要结局
- Average Rhinoconjunctivitis Total symptom Score(~1 month (whole birch pollen season))
- Rescue Medication Score(~1 month (whole birch pollen season))
- Average Combined Score(~1 month (whole birch pollen season))
- Global evaluation by the patient(after 5-6 months of treatment)
- Proportion of symptom-controlled days(~1 month (whole birch pollen season))
- Immunological markers (IgE and IgG4)(6-7 months)
- Sensitisation status(At least 6 months)
- Lower airways symptoms(~1 month (whole birch pollen season))
- Safety assessments(6-7 months)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability Study of rBet v1 SLIT TabletsBirch Pollen-Related RhinoconjunctivitisRhinitis, Allergic, SeasonalNCT00889460Stallergenes Greer55
已完成
2 期
Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)Hidradenitis SuppurativaNCT05093855Staidson (Beijing) Biopharmaceuticals Co., Ltd41
已完成
3 期
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and TriglyceridesDyslipidemia, Hypercholesterolemia, HypertriglyceridemiaNCT00812955AstraZeneca474
已完成
2 期
BTRX-246040 Study in Participants With Parkinson's Disease With Motor FluctuationsMotor DisorderParkinson DiseaseNCT03608371BlackThorn Therapeutics, Inc.24
终止
2 期
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)Lymphoma, B-cellLymphoma, Large B-cell, DiffuseNCT01925612Seagen Inc.87