Evaluation of Natural Human Interferon Alpha Lozenges in the Treatment of Chronic Cough in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- frequency/severity of cough
研究概览
简要总结
The purpose of this study is to determine whether lozenges containing interferon-alpha can reduce the frequency and severity of coughing in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).
详细描述
Both chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) frequently lead to a chronic cough that negatively impacts the quality of life (QOL) for patients and those around them. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges given 3 times per day for 4 weeks, can reduce the frequency and severity of chronic cough in patients with COPD or IPF. Cough frequency will be assessed via 24-hour digital audio recordings made prior to entry, and at weeks 2 and 4 of treatment. Cough severity will be assessed via a 100-mm visual analog scale questionnaire completed by the subject prior to entry and then weekly during treatment. Subjects will also complete questionnaires regarding cough frequency, duration and intensity, QOL, dyspnea, and antitussive medication usage weekly during treatment. All questionnaires will be repeated weekly during a 4-week post-treatment observation period to assess durability of response.
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
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all patients
- •history of clinically significant chronic cough for > 3 months
- •For COPD patients
- •>40 years of age
- •20-pack-year history of smoking
- •GOLD classification of Stage 1 or higher
- •For IPF patients
- •> 50 years of age
- •history of unexplained dyspnea on exertion of > 3 months
- •exhibits coughing and bilateral, basilar, inspiratory crackles on physical exam
- •presents as being in a stable phase of IPF
- •lung biopsy or HRCT indicative of IPF
排除标准
- •ACE inhibitor use
- •current cancer or history of lung cancer
- •non-ambulatory
- •hospitalized in the previous 12 months for heart failure
研究组 & 干预措施
1
lozenges containing 150 IU of natural human interferon-alpha
干预措施: interferon-alpha lozenges (Drug)
2
matching placebo lozenges
干预措施: placebo lozenges (Drug)
结局指标
主要结局
frequency/severity of cough
时间窗: weekly
次要结局
- quality of life(weekly)
- anti-tussive medication usage(weekly)
- dyspnea(weekly)
