Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Scores of the St.George's Respiratory Questionnaire
研究概览
简要总结
Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease (COPD) and asthma. However, there is no supporting evidence for their efficacy in the treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with theophylline in subjects with non-cystic fibrosis bronchiectasis.
详细描述
For the reasons of lack of sufficient clinical trial evidences, there are no standard therapy recommendations for bronchiectasis. Currently the treatments for bronchiectasis are mostly based on experience gained from the treatment of COPD and cystic fibrosis(CF). The aims of treatment for bronchiectasis are to improve the health-related quality of life, to slow down the decrease of lung function, to reduce the exacerbation frequence and the mortality. The mechanism of treatment are including: treating the underlying disease; improving drainage of sputum; anti-infection; anti-inflammation; treating airway obstruction. A review written by Peter J. Barnes describes that as a bronchodilator in COPD, theophylline may relax human airways smooth muscle, have an anti-inflammation rols, and have an additional effect on mucociliary clearance. Besides, theophylline can improve the activity of histone deacetylase, which will reverse the resistant of corticosteroids. We hypothesis that theophylline will have the same effect in subjects with NCF-bronchiectasis as in subjects with COPD. Our trial may give an evidence of using theophylline in treatment of bronchiectasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-70 years old with non-CF bronchiectasis ,free from acute exacerbations for at least 3 months.Stable phase of the disease.
排除标准
- •Patients with a cigarette smoking history of more than 10 packs-year. Patients with COPD. Patients with traction bronchiectasis due to advanced fibrosis. Patients with known intolerance for theophylline. Patients with asthma. Patients with other disease disturbing outcomes of the trials. Patients without consent.
研究组 & 干预措施
Theophylline
Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks
干预措施: Theophylline (Drug)
placebo
Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks
干预措施: Placebo(for Theophylline) (Drug)
结局指标
主要结局
Scores of the St.George's Respiratory Questionnaire
时间窗: At 24 weeks
次要结局
- 24 Hour Sputum Volume(Every day for 24 weeks)
- Activity of histone deacetylase(HDAC)(At 24 weeks)
- The Number of Exacerbations(At 24 weeks)
- Scores of The Leicester Cough Questionnaire(At 24 weeks)
- Activity of histone acetyltransferase(HAT)(At 24 weeks)
- Lung function(At 24 weeks)
- Induced sputum culture(At 24 weeks)
- Induced Sputum Cytology Count(At 24 weeks)
- Interleukin-6(IL-6)(At 24 weeks)
- C-Reactive Protein(At 24 weeks)
- To evaluate change in patients' Clinical Data(Every day for 24 weeks)
- Number of participants with adverse events(Up to 24 weeks)
- Plasma Concentration of Theophylline(At 24 weeks)
- IL-10(At 24 weeks)
- IL-8(At 24 weeks)
- Human Tumor Necrosis Factor α（TNF-α)(At 24 weeks)
- 8-Isoprostane(At 24 weeks)
- Blood routine examination(At 24 weeks)
研究者
Xugang
Doctor of Medicine
The First Affiliated Hospital of Guangzhou Medical University