Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Nasal patency evaluated by acoustic rhinometry.
研究概览
简要总结
The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 6-16 years of age with a history of AR in the previous year
- •T5SS: ≥5 in the last week before enrollment
排除标准
- •asthma symptoms
- •acute upper respiratory infections
- •anatomic nasal defects (ie, septum deviation), or nasal polyps
- •use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.
研究组 & 干预措施
Beclometasone Dipropionate (BDP)
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days.
干预措施: Nasal Beclomethasone Dipropionate (Drug)
CERCHIO 10 mg/ml OS
For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days.
干预措施: CERCHIO 10 mg/ml OS (Drug)
结局指标
主要结局
Nasal patency evaluated by acoustic rhinometry.
时间窗: 21 days
The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days.
次要结局
- Efficacy of Beclometasone nasal spray on subjective nasal symptoms(21 days)
研究者
Stefania La Grutta, MD
MD, Senior Researcher, Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica