Prevalence and Main Features of Chronic Refractory Cough. (ASSESS-CRC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cough

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Antonio De Vincentis, MD; Phone Number: 06225411445; Email: a.devincentis@unicampus.it
• Study Contact Backup: Name: Antonio De Vincentis, MD; Phone Number: 062254114445; Email: a.devincentis@unicampus.it

Study Locations

• Italy
  • Roma, Italy, 00146
    • Campus Bio-Medico di Roma
    • Contact: Antonio De Vincentis, MD; Phone Number: 06 2254114445; Email: a.devincentis@unicampus.it
  • Roma, Italy, 00146
    • IRCCS Maugeri Tradate
    • Contact: Antonio Spanevello; Phone Number: 331829111; Email: antonio.spanevello@icsmaugeri.it
  • Roma, Italy, 00146
    • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
    • Contact: Luca Richeldi; Phone Number: 06 30151; Email: luca.richeldi@unicatt.it
  • Roma, Italy
    • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
    • Contact: Roberto Bernabei; Phone Number: 06 30151; Email: roberto.bernabei@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• complaining chronic cough (lasting more than 8 weeks)

Exclusion Criteria:

• Unwilling to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic cough; Subject complaining cough from at least 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients complaining cough lasting more than 8 weeks during geriatric and respiratory specialist visits	to estimate the prevalence of chronic cough in different settings, i.e. in geriatric and in pneumology specialist clinics	2 years
Proportion of patients with chronic refractory cough on all patients with chronic cough coming to medical attention during geriatric or respiratory specialist visits	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.	2 years
describe the clinical and demographic characteristics (age, sex, comorbidities, smoke hystory, type of cough presentation, educational level) of patients with chronic refractory cough	to define patient's socio-demographical and clinical characteristics associated with the diagnosis of chronic refractory cough	2 years

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Raffaele Antonelli Incalzi, MD, Campus Bio Medico

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 1, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: ComEtx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No