Pilot Study of Zinc Acetate for Chronic Cough

醋酸锌治疗慢性咳嗽的初步研究

• 批准号: 9115284
• 负责人: BRENDAN J CANNING
• 金额: $ 28.53万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9115284
• 关键词: Accounting; Acute; Address; Adverse effects; American Lung Association; Angiotensin-Converting Enzyme Inhibitors; Animal Model; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Antitussive Agents; Asthma; Characteristics; Chemicals; Chronic; Clinical Research; Clinical Trials; Consensus; Consultations; Coughing; Disease; Distress; Divalent Cations; Dose; Enrollment; Enzymes; Fatigue; Futility; Gastroesophageal reflux disease; Guidelines; Health; Hepatolenticular Degeneration; Human; Hypersensitivity; Impairment; Infection; Isoenzymes; Laboratories; Lung; Lung diseases; Measures; Mechanics; Medical; Mucositis; Multicenter Trials; Na(+)-K(+)-Exchanging ATPase; Nose; Oral; Outcome Measure; Participant; Patients; Pilot Projects; Primary Care Physician; Property; Protein Isoforms; Psychometrics; Quality of life; Randomized; Randomized Clinical Trials; Refractory; Reporting; Rhinovirus; Safety; Sinusitis; Site; Sleep Deprivation; Smoking; Social isolation; Specialist; Upper Respiratory Infections; Zinc; Zinc Acetate; Zinc supplementation; afferent nerve; airway hyperresponsiveness; base; cohort; design; dietary supplements; effective therapy; irritation; medical specialties; novel therapeutics; pre-clinical; public health relevance; receptor; receptor sensitivity; tool

 DESCRIPTION (provided by applicant): Cough is the most common medical condition presenting to primary care physicians. Chronic cough is defined by persistence longer than eight weeks. Chronic refractory cough that does not respond despite treatment for specific aggravating conditions or empiric treatment accounts for up to 20% of new pulmonary specialist referrals. The general scientific consensus is that such patients suffer from hypersensitivity of the airway cough receptors. However, the few available antitussive treatment options are limited by adverse effects, lack of efficacy, and abuse potential. Recent evidence has identified the key cough receptors of the human airway and has identified the specific isoform of Na-K-ATPase that modulates the sensitivity of these receptors. The divalent cation Zinc is a relatively specifi blocker of this enzyme and decreases cough sensitivity in animal models. In humans, Zinc in adequate doses has been effective in reducing cough duration after rhinovirus infections. Further, zinc has a strong safety record as a nutritional supplement and as a treatment for Wilson's disease. Accordingly, we are proposing two studies to inform the design and feasibility of a definitive trial of zinc acetate 150 mg/day (Galzin (r)) for patients with chronic refractory cough. The first study is a pilot randomized clinical trial in 36 patients treated with either placbo or 150 mg Zinc acetate daily. This trial will determine whether a definitive trial is feasible and non-futile. The second study is a panel study of 100 patients to determine the statistical and psychometric characteristics of the proposed patient-reported cough outcome measures. The trials will be conducted by the American Lung Association Airways Clinical Research Centers (ALA-ACRC) which has a long-standing successful track record for clinical trials.

 描述（由应用程序提供）：咳嗽是向初级保健医生提供的最常见的医疗状况。慢性美洲狮的定义是持续时间超过八周。对特定的聚集条件或经验治疗不反应的慢性难治性美洲狮最多占新肺部专家转介的20％。一般的科学共识是，此类患者患有气道美洲狮受体过敏。但是，少数可用的抗气治疗方案受到不利影响，缺乏效力和滥用潜力的限制。最近的证据已经确定了人类气道的关键美洲狮受体，并确定了调节这些受体敏感性的Na-K-ATPase的特异性同工型。二价阳离子锌是该酶的相对特异性阻滞剂，并降低了动物模型中的美洲狮灵敏度。在人类中，足够剂量的锌在减少鼻病毒感染后的牛持续时间有效。此外，锌作为营养补充剂具有很强的安全记录，并作为威尔逊氏病的治疗方法。彼此之间，我们提出了两项​​研究，以告知乙酸锌150毫克/天（Galzin（R））的设计和可行性。第一项研究是一项针对36例持续治疗或乙酸锌锌150 mg的患者的试验随机临床试验。该试验将确定确定的试验是否可行且不适用。第二项研究是对100名患者进行的小组研究，以确定拟议的患者报告的COUG结果指标的统计和心理测量特征。试验将由美国肺协会Airways Airways临床研究中心（ALA-ACRC）进行，该研究中心具有长期成功的临床试验记录。