A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
研究概览
简要总结
Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway. This manifestation of the disease leads to the common complaint of persistent dry cough that is seen in many of these patients. This study is aimed at determining whether the regular use of Pulmozyme will result in decreased cough and improved quality of life.
详细描述
Patients with Sjogren's disease have destruction of the mucus secreting cells in the bronchi. This manifestation of the disease leads to the common complaint of persistent dry cough that is seen in many of these patients. The investigators theorize that regular use of Pulmozyme will result in decreased cough and improved quality of life, by improving mucus clearance.
Primary Objective:To determine if the use of Pulmozyme, twice a day improves cough-related quality of life or cough severity in patients with chronic cough due to Sjogren's disease.
Secondary Objectives:
- To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
- To determine the effect of Pulmozyme use on pulmonary function in patients with chronic cough due to Sjogren's disease.
- To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above with primary Sjogren's disease (as defined by the American European Consensus Group Criteria), and complaint of chronic cough.
- •Able to give consent and anticipated ability to adhere to the study procedures.
排除标准
- •Diagnosis of COPD, emphysema, asthma, chronic bronchitis, other clinically significant lung disease that is likely to cause cough. Interstitial lung disease associated with Sjogren's is not excluded.
- •Cigarette use of greater than 20 pack years or regular use within 6 months
- •Allergy or intolerance to Pulmozyme.
- •Acute respiratory infection or other acute respiratory illness during the prior month.
- •LCQ greater than 17 and VAS less than 3 cm at baseline (Visit 1).
- •Pregnancy or breast feeding.
研究组 & 干预措施
Dornase alfa (Pulmozyme)
Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.
干预措施: Saline (Drug)
Saline
Normal saline 0.9% solution
干预措施: Dornase alfa (Drug)
Saline
Normal saline 0.9% solution
干预措施: Saline (Drug)
结局指标
主要结局
Changes in Leicester Cough Questionnaire (LCQ) score and cough visual analog scale.
时间窗: After 2 weeks of therapy.
To determine if the use of Pulmozyme, twice a day improves cough-related quality of life or cough severity in patients with chronic cough due to Sjogren's disease.
次要结局
- Change in spirometry, specifically FEV1, FVC, FEV1/FVC and FEF 25-75%(After 2 weeeks of therapy)
- To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.(At start of study)
- To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.(After 2 weeks of therapy.)