Randomized, Double-blind, Placebo-controlled Study to Measure 2L®ALERG (Homeopathic Drug) Efficacy on Symptoms of Allergic Rhinitis and Allergic Rhinoconjunctivitis in Patients With a Seasonal Allergy to Grass Pollen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)
研究概览
简要总结
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to rescue medication intake. The secondary objectives are to compare the allergy symptoms, the rescue medication intake, the quality of life and the safety in patients treated with 2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two months before traditional pollen peak, then visits at 3 months and 6 months, or end of the peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order of 1 to 10 capsules for 6 months.
The placebo will have the same form, colour, taste and aspect. The allowed concomitant treatments are the already established treatments for associated pathologies not liable to have an impact on the proper conduct of the study and the rescue medications allowed in the first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those above]).
The prohibited treatments are the oral or injectable corticosteroids and the anti-leukotrienes.
详细描述
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to rescue medication intake. The secondary objectives are to compare the allergy symptoms, the rescue medication intake, the quality of life and the safety in patients treated with 2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two months before traditional pollen peak, then visits at 3 months and 6 months, or end of the peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order of 1 to 10 capsules for 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male and female
- •Woman of childbearing age using effective contraceptive means
- •Patient having the faculties to understand and respect the constraints of the study
- •Symptomatic since at least two seasons and confirmed by positive skin test and/or the presence of IgE for grasses (prick test defined as positive if higher than or equal to half the negative control; IgE positive if at least class 3 (≥ 3.5 kU / L); these tests must have been performed at the latest at the first screening visit
- •Signature of the Informed Consent Form
排除标准
- •Pregnant woman or woman wishing to become pregnant
- •Breastfeeding woman
- •Patient with an acute exacerbation of allergic rhinitis
- •Patient with uncontrolled asthma
- •Immunotherapy received within the last two years
- •Patient with a known lactose intolerance
- •Patient who participated in a clinical study in the previous three months
- •Patient who is not sufficiently motivated to engage on a follow-up period of 6 months or more, unable to complete the patient diary, or likely to travel or to move before the end of the study,
- •Patient taking nasal or bronchial inhaled corticosteroids on a long term basis (intermittent consumption during the season is permitted provided it is mentioned in the patient's records)
研究组 & 干预措施
Placebo
Non-impregnated lactose saccharose globules (380 mg/capsule)
干预措施: Placebo (Drug)
2LALERG
Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH
Impregnated on lactose saccharose globules (380 mg/capsule)
干预措施: 2LALERG (Drug)
结局指标
主要结局
Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)
时间窗: Up to Month 6 (end of pollen season)
Area under the curve \[AUC\] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.
次要结局
- Quality of Life During the Whole Period of Observation(QoL scores were assessed daily for up to 6 months)