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临床试验/NCT04078542
NCT04078542Unknown不适用

Assessing Prevalence and Main Features of Chronic Refractory Cough in Different Specialist Settings.

Campus Bio-Medico University3 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
3
主要终点
Proportion of patients with chronic refractory cough on all patients with chronic cough coming to medical attention during geriatric or respiratory specialist visits

研究概览

简要总结

Cough is among the most common causes of medical consultation in primary care.[1] Chronic cough, arbitrarily defined as symptom persisting more than 8 weeks, has been variably reported in different settings and geographical area, with an overall prevalence of 10-20% in the general population, that increases up to 40-50% in pneumology specialist clinics.[2,3] While acute cough is generally caused by the common cold and typically lasts one to three weeks, chronic persisting cough can underlie more serious disease processes. Moreover, it can impair quality of life,[4] possibly leading to tiredness, urinary incontinence, and eventually syncope. It also has psychosocial effects such as embarrassment and negative impact on social interactions.

A careful clinical history may provide important diagnostic clues that allow therapeutic trials without the need of further investigations.[5] Smoking history, medication list and presence and character of sputum should be carefully detailed. Identification of the causes of productive cough is generally straightforward and strategies for intervention and treatment are well defined.[5] Conversely, chronic dry or poorly productive cough represents a greater diagnostic challenge. Several studies have shown that in nonsmokers with normal chest radiography who are not taking ACE-inhibitor, chronic cough is usually due to asthma, rhinosinusitis or gastro-esophageal reflux (GER).[6] Many dedicated algorithms have been identified to guide the diagnostic phase and to sequentially coordinate the execution of further diagnostic deepening and/or empirical treatments, based on cost-effectiveness principles.[5,7-9] Among these, the European Respiratory Society (ERS) recommendations[5] are widely applied in clinical practice and broadly parallel those released by the American College of Chest Physicians[7]. This notwithstanding, a proportion of cases do not reach a definite diagnosis and resolutive treatment[7]. This condition is termed chronic refractory cough (CRC), chronic idiopathic cough, or unexplained chronic cough.[7,10] It can be diagnosed when patients have no identified causes of chronic cough (unexplained or idiopathic chronic cough) or when the cough persists after investigation and treatment of cough-related conditions. Because patients with unexplained chronic cough often receive specific therapies, such as inhaled corticosteroids or proton pump inhibitors, they can also be classified as having CRC.

The real prevalence of CRC is not well-know and many cases of CRC may be actually misdiagnoses due an incomplete application of recommended work-up. In the present study we aim to estimate the prevalence of chronic cough in different care settings, together with the prevalence of CRC according to a systematic and integrated approach. The careful application of the recommendation defined by ERS guidelines will allow to detect truly refractory cases of chronic cough.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • complaining chronic cough (lasting more than 8 weeks)

排除标准

  • Unwilling to participate

结局指标

主要结局

Proportion of patients with chronic refractory cough on all patients with chronic cough coming to medical attention during geriatric or respiratory specialist visits

时间窗: 2 years

to estimate the prevalence of chronic refractory cough (CRC) in subject with chronic cough - CRC will be diagnosed if cough persists despite guideline based management - In particular, CRC will be defined as cough persisting after a complete diagnostic work-up and despite extended trials of empirical therapy.

describe the clinical and demographic characteristics (age, sex, comorbidities, smoke hystory, type of cough presentation, educational level) of patients with chronic refractory cough

时间窗: 2 years

to define patient's socio-demographical and clinical characteristics associated with the diagnosis of chronic refractory cough

Proportion of patients complaining cough lasting more than 8 weeks during geriatric and respiratory specialist visits

时间窗: 2 years

to estimate the prevalence of chronic cough in different settings, i.e. in geriatric and in pneumology specialist clinics

次要结局

未报告次要终点

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raffaele Antonelli Incalzi

Full Professor of Internal Medicine

Campus Bio-Medico University

研究点 (3)

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