Clinical trial NCT04078542: Prevalence and Main Features of Chronic Refractory Cough.
Official title: Assessing Prevalence and Main Features of Chronic Refractory Cough in Different Specialist Settings.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cough
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be screened for the presence of cough and those complaining chronic cough (i.e. lasting more than 8 weeks) will be included. Only subjects aged less than 18 years will be excluded and no other specific exclusion criteria will be adopted, in order to gather data on a real life population.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* complaining chronic cough (lasting more than 8 weeks)

Exclusion Criteria:

* Unwilling to participate

Primary outcomes:
measure: Proportion of patients complaining cough lasting more than 8 weeks during geriatric and respiratory specialist visits
timeFrame: 2 years
measure: Proportion of patients with chronic refractory cough on all patients with chronic cough coming to medical attention during geriatric or respiratory specialist visits
timeFrame: 2 years
measure: describe the clinical and demographic characteristics (age, sex, comorbidities, smoke hystory, type of cough presentation, educational level) of patients with chronic refractory cough
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: IRCCS Maugeri Tradate
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
Study officials:
affiliation: Campus Bio Medico
name: Raffaele Antonelli Incalzi, MD
role: PRINCIPAL_INVESTIGATOR
References: