CoughASSESS-CRCNCT04078542
Prevalence and Main Features of Chronic Refractory Cough.
An observational study of Cough, run by Campus Bio-Medico University at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cough
- How many people
- 400 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- complaining chronic cough (lasting more than 8 weeks)
Who cannot join
- Unwilling to participate
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Campus Bio-Medico di Roma
Roma, 00146
Antonio De Vincentis, MD, 2254114445 ext. 06, a.devincentis@unicampus.it
IRCCS Maugeri Tradate
Roma, 00146
Antonio Spanevello, 331829111, antonio.spanevello@icsmaugeri.it
Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
Roma, 00146
Luca Richeldi, 30151 ext. 06, luca.richeldi@unicatt.it
Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
Roma
Roberto Bernabei, 30151 ext. 06, roberto.bernabei@unicatt.it
About this study
Official title: 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.
- Conditions
- Cough
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic cough | Subject complaining cough from at least 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele Antonelli Incalzi, Campus Bio-Medico University
- Investigators
- Raffaele Antonelli Incalzi, MD, Principal investigator, Campus Bio Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078542
- Sponsor's protocol ID
- ComEtx
- Acronym
- ASSESS-CRC
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Prevalence and Main Features of Chronic Refractory Cough in Different Specialist Settings.
- ClinicalTrials.gov ID
- NCT04078542
- Acronym / sponsor ID
- ASSESS-CRC / ComEtx
- Conditions
- Cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic cough | – | –Subject complaining cough from at least 8 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- complaining chronic cough (lasting more than 8 weeks)
Key exclusion criteria (1 listed)
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients complaining cough lasting more than 8 weeks during geriatric and respiratory specialist visits
Time frame: 2 years
to estimate the prevalence of chronic cough in different settings, i.e. in geriatric and in pneumology specialist clinics
Proportion of patients with chronic refractory cough on all patients with chronic cough coming to medical attention during geriatric or respiratory specialist visits
Time frame: 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
Time frame: 2 years
to define patient's socio-demographical and clinical characteristics associated with the diagnosis of chronic refractory cough
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Antonelli Incalzi, MD principal investigator
Campus Bio Medico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by Campus Bio-Medico University at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio De Vincentis, MD (06225411445, a.devincentis@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients complaining cough lasting more than 8 weeks during geriatric and respiratory specialist visits (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.