NCT04729517已完成3 期
Randomized Multicenter Phase III Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)
Abdi Ibrahim Ilac San. ve Tic A.S.1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年4月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Total Nasal Symptom Score
研究概览
简要总结
This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.
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
- None
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
- •To be diagnosed as allergic rhinitis on the basis of medical history, physical examination, and skin prick test, and according to ARIA 2008 criteria
- •To be included in seasonal and perennial allergic rhinitis group
- •To have a related complaint for at least 2 years
- •To be informed about the study and to give consent to participate in the study
排除标准
- •Diagnosis of superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration and nasal septum perforation during nasal examination
- •Presence of nasal diseases that are likely to affect the accumulation of intranasal drugs, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
- •Having undergone a nasal or sinus surgery for up to one year before the study
- •The use of systemic or topical steroids within the last 15 days prior to inclusion in the study
- •The use of antihistamine, chromoline Na within the last 15 days prior to inclusion in the study
- •The use of any investigational drug within 30 days prior to Visit 1;
- •Known hypersensitivity to components of the products used in the study
- •Presence of respiratory infections, which have developed within the two weeks prior to Visit 1
- •Diagnosis of COPD
- •A history of alcohol or drug addiction treatment within the last 2 years prior to inclusion in the study, or any current addiction on alcohol or drugs,
- •Use of alcohol and other drugs (antidepressants) that have a negative effect on reaction time / concurrent use of sedative drugs or other drugs that act on the central nervous system
- •Presence of significant lung diseases including asthma. ((Only patients with intermittent asthma who need short-acting inhaled bronchodilators (no more than twice a week) and do not wake up at night due to asthma are suitable for inclusion)).
- •Presence of chronic obstructive sleep-apnea syndrome (clinical diagnosis)
- •Presence of any surgical or medical condition, which, according to the opinion of the responsible researcher, could significantly alter the absorption, distribution, metabolism, or excretion of the investigational product, or could significantly affect the patient's ability to complete this study
- •Presence of symptoms in the medical history in relation to glaucoma, cataract, ocular herpes simplex, conjunctivitis, or other ocular infections
- •Presence of medical history in relation to active or latent tuberculosis
- •Presence or risk of exposure to chickenpox or measles within the last 30 days
- •Presence of untreated fungi, bacteria or systemic viral infection within the last 30 days
- •Being pregnant or breastfeeding
- •Women of reproductive age who do not use a medically valid contraceptive method
- •Presence of cystic fibrosis
- •Presence of primary ciliary dyskinesia
- •Use of intranasal or systemic first-generation antihistamines, leukotriene receptor antagonists or other nasal decongestants during the study
- •Use of any ophthalmic steroid or nasal, inhaled or systemic steroid during the study
- •Use of another clinical research product during the study
研究组 & 干预措施
Azelastine Hydrochloride
Active Comparator
Patients that will receive azelastine hydrochloride are defined as the active control arm.
干预措施: Azelastine Hydrochloride (Drug)
AI201901
Experimental
Patients that will receive AI201901 are defined as the test arm.
干预措施: AI201901 (Drug)
结局指标
主要结局
Total Nasal Symptom Score
时间窗: 28 days
Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS).
次要结局
- TNNSS; Total non nasal symptom score(28 days)
- Odor Visual Analogue Score (VAS)(28 days)
- Inspiratory peak flow meter (PNIF)(28 days)
- The rhinoconjunctivitis quality of life scale (RQLQ)(28 days)
- Connecticut butanol odor threshold test(28 days)
- Rhinoscopic Assessment Scale(28 days)
- Safety of AI201901(28 days)
研究者
研究点 (1)
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