COllaboration REsearch on Chronic Cough (COREC): a French Multicenter Database

NCT ID: NCT04882943

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 576 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2026-06-01

Brief Summary

Chronic cough (TC), defined by a duration exceeding 8 weeks, is a particularly frequent symptom with a prevalence observed at 9.6% 1. Chronic cough is the cause of a major handicap for patients with a impact on their quality of life 2.

Although CT is common, management is often delicate and complex. In studies, asthma, gastroesophageal reflux disease, posterior flushing, rhino-sinusitis, or taking tussigenic medications are common causes of chronic coughs. However, chronic refractory or unexplained cough, which corresponds to cough for which no cause has been found or the treatments directed against the cause of the cough have not made it possible to resolve the cough, is a real problem in practice. nick3.

There is currently no prospective data in France on the characteristics of chronic cough (etiologies, response to treatment) and the percentage of refractory cough.

The aim of the study is to constitute a French prospective multicenter hospital cohort of chronic cough patients in order to identify, for the first time in France in a prospective and multicenter manner, the frequency of patients with refractory cough among chronic cough patients.

Detailed Description

Visit V1: Visit as part of the treatment After obtaining no objection, the patient will complete cough questionnaires

Visit V2: Visit as part of the treatment Visit carried out at 3 months with evaluation of the cough on the criteria of severity and quality of life. An evaluation of the response to treatments initiated at visit V1 will be carried out.

Visit V3: Visit as part of the treatment Visit carried out at 6 months either by telephone if response to treatment at 3 months (at the discretion of the investigators) or in the investigative center if no response to treatment at 3 months. An evaluation of the cough on the criteria of severity and quality of life will be performed.

Visit V4 to V8: Visit within the framework of research Phone call every 6 months made by a research technician. Patient severity and quality of life questionnaires will be issued in advance and completed at the time of telephone contact.

The end of research visit corresponds to the V8 visit.

Conditions

Refractory Chronic Cough

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with unexplained or refractory chronic cough

Patients with cough lasting for more than 8 weeks (duration corresponding to the definition of chronic cough)

questionnaires

Intervention Type: OTHER

Quality of life questionnaires

Interventions

questionnaires

Quality of life questionnaires

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years old
• Consultation motivated by cough lasting for more than 8 weeks (duration corresponding to the definition of chronic cough)
• Patient covered by a National Health Insurance

Exclusion Criteria

• Active smoker or recent smoking cessation (within the past 6 months)
• Intake of medications causing cough (the patient can be included 4 weeks after treatment discontinuation if cough persists)
• Pregnant or breast-feeding women
• Upper or lower respiratory tract infection within the past 4 weeks
• Active lung disease (such as interstitial lung disease, lung cancer, abnormal dilation of the bronchi).
• History of chronic bronchitis.
• Current treatment with an angiotensin converting enzyme (ACE) inhibitor
• History of cancer within the past 5 years or active cancer (excluding cutaneous squamous-cell carcinoma).
• Person not fluent in French
• Adult not able to express his/her consent verbally
• Patient refusal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MSD France

INDUSTRY

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent GUILLEMINAULT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

UHToulouse

Toulouse, , France

Countries

France

Other Identifiers

2020-A02774-35

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/20/0378

Identifier Type: -

Identifier Source: org_study_id