Evaluation of the Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents: a Multicenter, Double-blind, Randomised, Placebo Controlled, Parallel Group Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- clinically relevant changes in vital signs
研究概览
简要总结
Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events.
The aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients. It is assumed that Ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of SAR.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-17 years
- •diagnosed seasonal allergic rhinitis
- •general good health condition other than SAR, and free of any concomitant conditions or treatment that could interfere with clinical investigation conduct, influence the interpretation of clinical investigation observations/results, or put the patient at increased risk during the clinical investigation
- •Sum of Total Nasal Score (TNSS) ≥ 6
- •Sum of Total Ocular Score (TOSS) ≥ 4
排除标准
- •- Confirmed diagnosis of acute or chronic rhinosinusitis, as determined by the investigator
- •History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit)
- •Chronic or intermittent use of intranasal, oral, intramuscular, intravenous or ophthalmic corticosteroids
- •Ocular disorder other than allergic conjunctivitis, except hyperopia and myopia and strabismus
- •Upper and lower airway respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within 4 weeks prior to clinical investigation start or development of a respiratory infection during the run-in period
- •Start of specific immunotherapy within 1 month preceding enrolment in the clinical investigation or change in dose of immunotherapy throughout the trial
- •Chronic moderate to severe asthma according to GINA criteria which is treated with inhaled corticosteroids (ICS) and additional anti-asthmatic treatment. Patients with mild co-seasonal asthma must not change their dose regimen of ICS within 4 weeks prior to the enrolment into the clinical investigation nor during the clinical investigation
- •Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, emphysema, etc.)
- •on investigators discretion
研究组 & 干预措施
Ectoin products
干预措施: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) (Device)
Placebo products
干预措施: Placebo products (Device)
结局指标
主要结局
clinically relevant changes in vital signs
时间窗: 2 weeks
Incidence of adverse events
时间窗: 2 weeks
Change score in TOSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
时间窗: 2 weeks
Total ocular symptom score: itchy eyes, red eyes, watery eyes´on a 4 point scale (0=none to 3=severe) assessed by the patient/caregiver
clinical relevant changes in physical examination parameters
时间窗: 2 weeks
Severity of Adverse events
时间窗: 2 weeks
Change score in non-nasal score at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
时间窗: 2 weeks
Non-nasal score: itchy ear/palate on a 4 point scale (0=none to 3=severe)assessed by the patient/caregiver
Overall assessment by the patient (Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ for children aged 5-12 years or AdolRQLQ for adolescents aged 13-17 years)
时间窗: 2 weeks
Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
时间窗: 2 weeks
Total nasal symptom score: runny nose (anterior rhinorrhea/postnasal drainage), itchy nose, nasal congestion (stuffy nose) and sneezing on a 4 point scale (0=none to 3= severe)asssessed by the patient/caregiver
次要结局
- Symptom scores separately for a.m. and p.m. measurement over time(2 weeks)
- TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time(2 weeks)
- TNSS, separately for a.m. and p.m. measurement over time(2 weeks)
- Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time(2 weeks)
- Use of rescue medication(2 weeks)