The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Improvement in Appearance of Nasal Passages/Sinuses
研究概览
简要总结
Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.
详细描述
AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF)
PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively.
Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months.
Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and laboratory diagnosis of cystic fibrosis
- •Age greater than or equal to 5 years
- •Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
- •Sinus surgery within one week of enrollment
排除标准
- •Pregnancy
- •Intolerance of orally inhaled Pulmozyme (dornase alfa)
研究组 & 干预措施
Pulmozyme
2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily
干预措施: Pulmozyme (dornase alfa) (Drug)
placebo
2.5 mg/2mL placebo administered intranasally once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Appearance of Nasal Passages/Sinuses
时间窗: baseline and 1 year
periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome). independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)
Computed Tomography Evidence of Less Sinus Disease
时间窗: baseline and 1 year
compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)
次要结局
- Chronic Sinusitis Survey Score(baseline and 1 year)
- Pulmonary Function(baseline and 1 year)
研究者
Thomas Lahiri
Professor of Pediatrics
University of Vermont