The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 98
- 主要终点
- improvement of the nasal signs and symptoms.
研究概览
简要总结
Gastroesophageal(GERD) reflux disease is a very common problem among pediatric population and has be proved to contribute in numerous otolaryngological manifestations. Trails of empirical treatment of antireflux medications is often used as a diagnostic test. However, the investigators believe GERD can cause rhinitis and nasal obstruction. Nasonex is considered as first line treatment for nasal obstruction. Hence, the proposed study aims to define the relationship between GERD and rhinitis using randomize control trial where one group of patients will receive nasonex and placebo, while the other group will receive nasonex and antireflux medications.
详细描述
The proposed study is a randomized controlled trial in which children with nasal obstruction will be randomized to receive either antireflux medication lansoprazole (prevacid) and mometasone furonate (nasonex) or only nasonex and placebo. The diagnosis of nasal obstruction will be made by history and physical examination.
The study will take place at Montreal children's hospital. After the patients or parents of the patients agree for their children to take part in the study and sign a consent/assent form, baseline information will be collected and the patients will asked to fill out three questionnaires for GERD symptoms and nasal symptom. After that eligible patients will undergo sinus x-ray, nasal endoscopy and allergy skin test (these test are routine performed for all patients with symptoms of nasal obstruction). Then the patients will further be sub-divided into two groups based on the allergic skin prick test (SPT); allergy positive and allergy negative group. In each group patients will randomly allocated to one of the two study arms; group A will receive lansoprazole (prevacid) and mometasone furonate (nasonex) and the other group will receive nasonex and placebo. The lansoprazole/placebo will be discontinued after 3 months and the patients will undergo nasal endoscopy and will be asked to fill out the three questionnaires again to assess the improvement. The patients will be follow for another 3 months, the patients will again undergo nasal endoscopy and will asked to fill out the three questionnaires to assess the improvement and sustainability.
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7 (seven) to 17 (seventeen) years of age.
- •Nasal obstruction as main complaint.
排除标准
- •Structural cause of nasal obstruction (deviated nasal septum, adenoid hypertrophy, nasal polyps, nasal tumors)
- •Received antireflux medication during the last three months.
- •Acute sinusitis
研究组 & 干预措施
treatment group
The treatment group will receive 30 mg lansoprazole (prevacid) one capsule per day for three months and mometasone furonate (nasonex) one puff in each nostril per day for three months.
干预措施: lansoprazole (Drug)
placebo group
The placebo group will receive one capsule per day of prevacid placebo for three months and mometasone furonate (nasonex) one puff in each nostril per day for three months.
干预措施: placebo (Drug)
结局指标
主要结局
improvement of the nasal signs and symptoms.
时间窗: three months
after three months of treatment the patient symptoms will be evaluated using subjective questionnaires and nasal endoscopic exam .
次要结局
未报告次要终点
研究者
John Manoukian
Associate Professor, Faculty of Medicine, McGill University, Department of Otolaryngology-Head and Neck Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre