Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches)
研究概览
简要总结
Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections.
The prospective placebo controlled cross-over study aims at the evaluation of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a confirmed diagnosis of cystic fibrosis based on: 3 positive sweat chloride tests and/or genetic characterisation
- •Subject is 5 years of age or older
- •Subject has chronic or recurrent rhinosinusitic disorders
- •Subject is able to comply with the procedures scheduled in the protocol
- •Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (e.g. implants, combined oral contraceptives, injectables, some IUDs, sexual abstinence or vasectomised partner)
排除标准
- •Subject has a critical condition defined as: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution
- •Subject had an ENT surgery within 6 months prior to study
- •Subject shows signs of nasal bleeding
- •Subject has an ear drum perforation
- •Subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy
- •Subject has a new therapy with nasal topic steroids during treatment interval
- •Subject has a new systemic steroid therapy
- •Subject is unlikely to comply with the procedures scheduled in the protocol
- •Subject has a known allergic reaction to the medication
- •Subject is pregnant or breastfeeding
- •Patient participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
研究组 & 干预措施
Dornase alfa
28 days of sinonasal inhalation (Pari Sinus)
干预措施: Dornase alfa (Pulmozyme) (Drug)
Dornase alfa
28 days of sinonasal inhalation (Pari Sinus)
干预措施: isotonic saline (Drug)
isotonic saline
28 days of sinonasal inhalation (Pari Sinus)
干预措施: Dornase alfa (Pulmozyme) (Drug)
isotonic saline
28 days of sinonasal inhalation (Pari Sinus)
干预措施: isotonic saline (Drug)
结局指标
主要结局
Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches)
时间窗: day 1, 29, 57 and 85
次要结局
- Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (secondary nasal parameters, general quality of live parameters and total SNOT 20 adapt. CF score)(day 1, 29, 57 and 85)
- Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients)(day 1, 29, 57, 85)
- Changes in the nasal lavage fluid and in the serological markers of inflammation(day 1, 29, 57 and 85)
- Changes in rhinoscopic findings(day 1, 29, 57 and 85)
- Changes in rhinomanometric findings(day 1, 29, 27 and 85)
- Incidence of rhinosinusitic and pulmonary exacerbations during therapy(day 1 - 85)
- Need for decongestants or nasal lavage during treatment(day 1 - 85)
研究者
PD Dr. Jochen G. Mainz
Head of CF Center
University of Jena