A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Clinical Trial Investigating the Efficacy and Safety of Pangramin SLIT HDM-mix in Chinese Population With House Dust Mite Induced Rhinitis With or Without Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 1
- 主要终点
- The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
研究概览
简要总结
Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma.
Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy.
This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.
详细描述
Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT and other SLIT products as named patient products, both with respect to the types and the frequencies of the adverse events(AEs) observed. No safety concerns have been found.
The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. The relationship between dose and effect is thus not fully elucidated. The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 5 to ≤ 55 years of age.
- •A history HDM induced allergic rhinitis.
- •Use of medication for the control of rhinoconjunctivitis symptoms.
- •Positive Skin Prick Test (SPT).
- •Positive specific IgE.
排除标准
- •PEF ≤ 70% of predicted value.
- •History of significant symptomatic seasonal or perennial allergic rhinitis and/or asthma caused by an allergen to which the patient is regularly exposed, and sensitized (e.g. pollens, cat, dog, cockroach...except house dust mites).
- •Severe asthma.
- •Current symptoms of upper respiratory tract infection or other relevant infectious process.
- •Current food allergies with oral allergy syndrome.
- •A clinical history of chronic sinusitis.
- •Current severe atopic dermatitis.
- •Concomitant or previous treatment by immunotherapy.
结局指标
主要结局
The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
时间窗: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary.
The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
时间窗: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms. 1. = Mild symptoms. 2. = Moderate symptoms. 3= Severe symptoms. The six symptoms are classified in 2 groups as follows: Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
次要结局
- The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.(Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).)
- The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.(Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).)
- The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.(Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).)
- Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.(Total study year)
- The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.(Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).)
- The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.(Visit 1 date(Week -8), Visit 9 date(Week 52).)
- Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.(Visit 9 date, Week 52)
- The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.(Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).)
- The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.(Visit 1 date(Week -8), Visit 9 date(Week 52).)
- The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated(Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).)