NCT03145051Unknown不适用
Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period.
研究概览
简要总结
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 11 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patient with Cystic Fibrosis with or without lung transplant;
- •Patients with allergic chronic rhino sinusitis or no allergic diagnosed by the clinical investigator on the basis of the following signs in variable combination: nasal congestion, headache, sneezing, itchy nose and eyes, runny nose, nosebleeds and nasal crusts, redness and eye discharge present more than 3 months per year.
- •Patient treated on an outpatient basis;
- •Patient agreeing not to take sea baths for the duration of the study;
- •Patient agreeing to respect the procedures for conducting the study, in particular the washout period and follow-up visits;
- •Patient capable of understanding and self-completing the questionnaires;
- •For juvenile patients, the holder (s) of parental authority have accepted the participation of the young person (by signing the informed consent after having taken note of the information note)
- •Member or beneficiary of a social security program
排除标准
- •Patients with significant obstruction of the nasal passages due to:
- •a mucocele,
- •polyposis causing nasal obstruction> 90% or
- •severe malformation of the septum causing a nasal obstruction> 90% in whom surgical treatment is recommended;
- •Patients with signs of severity that may require hospitalization, such as: severe impairment of general health, dyspnoea with cyanosis, high fever (> 40 ° C).
- •Patients requiring corticosteroid therapy during the study, with the exception of patients who received pulmonary transplant and were treated with oral corticosteroids at no more than 0.2 mg / kg / day.
- •Patients with known systemic immunodeficiency status with the exception of patients receiving pulmonary transplantation and immunosuppressed.
- •Patient pregnant (urine test) or without effective contraception (birth control pill, contraceptive patch, contraceptive implant, vaginal ring, intrauterine device or intrauterine device, male condom).
- •Nursing patient.
- •Patient with a contraindication to nasal irrigations as defined in the product leaflet.
研究组 & 干预措施
Saline solution
Active Comparator
Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device
干预措施: Saline solution (Other)
Respimer Netiflow mineral salts solution
Experimental
Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device
干预措施: Respimer Netiflow (Other)
结局指标
主要结局
Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period.
时间窗: over an 8 weeks period
Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire
次要结局
- Clinical status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.(over an 8 weeks period)
- Mucociliary transport change among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.(over an 8 weeks period)
- Endoscopic status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.(over an 8 weeks period)
- Evolution of nasal bacterial pathogens among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.(over an 8 weeks period)
- Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device(over an 8 weeks period)
- Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning(over an 8 weeks period)
研究者
研究点 (2)
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