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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04882943
Collaborator
MSD France (Industry)
576
1
60.8
9.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaires

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
576 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COllaboration REsearch on Chronic Cough (COREC): a French Multicenter Database
Actual Study Start Date :
May 6, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
patients with unexplained or refractory chronic cough

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

Other: questionnaires
Quality of life questionnaires

Outcome Measures

Primary Outcome Measures

  1. French prospective multicenter hospital cohort of chronic cough patients (requency of patients with unexplained or refractory chronic cough (URCC) [24 months]

    set up a French prospective multicenter hospital cohort of chronic cough patients in order to identify the frequency of patients with unexplained or refractory chronic cough (URCC) for the first time in France

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UHToulouse Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse
  • MSD France

Investigators

  • Principal Investigator: Laurent GUILLEMINAULT, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04882943
Other Study ID Numbers:
  • RC31/20/0378
  • 2020-A02774-35
First Posted:
May 12, 2021
Last Update Posted:
May 14, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2021