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Clinical Trial Summary

Patients will be recruited during a routine consultation with a physician in the hepato-gastroenterology department.

At the end of the consultation, patients will have to complete the following questionnaire: "European Community Respiratory Health Survey" which allows the screening of patients at risk of chronic respiratory diseases (asthma, COPD, bronchiectasis, emphysema).

In the event of a declaration of functional respiratory signs, a consultation with a pulmonologist will be systematically proposed. At the end of this consultation, if the doctor deems it necessary, further investigations will be proposed and/or regular follow-up organised.

The main objective of this study is to estimate the prevalence of respiratory symptoms leading to a diagnosis of chronic respiratory disease in patients with inflammatory bowel diseases (IBD) (Crohn's disease and UC).

The main criterion for judgement will be the frequency of functional respiratory signs (wheezing, dyspnea, cough, sputum) reported by IBD patients through an adapted self-report questionnaire.


Clinical Trial Description

Approximately one-third of IBD patients will develop systemic extra-digestive manifestations (joint, dermatologic or ophthalmologic) during the course of their disease and up to 25% will develop these systemic manifestations even before the diagnosis of IBD. Among these systemic affections, respiratory manifestations remain poorly known because they are not searched for in daily clinical practice.

The main objective of this study is to estimate the prevalence of respiratory symptoms leading to a diagnosis of chronic respiratory disease (asthma, COPD, bronchiectasis) in patients with IBD (Crohn's disease and UC).

Patients will be recruited during a routine consultation with a physician in the hepato-gastroenterology department as part of the management of their chronic inflammatory bowel disease.

During this consultation, the investigating physician will explain to the patient the objective of the study and check with him/her the eligibility criteria. The patient will then be given an information note. He or she may ask any questions he or she wishes and if he or she refuses to participate in the study, he or she will have to sign an objection form in duplicate (one copy will be given to the patient and the other will be kept in the medical file). The doctor will also sign these two copies.

At the end of the consultation, patients will have to complete the following questionnaire: "European Community Respiratory Health Survey" which allows the screening of patients at risk of chronic respiratory diseases (asthma, COPD, bronchiectasis, emphysema).

In the event of a declaration of functional respiratory signs, a consultation with a pulmonologist from the Department of Pulmonology of the CHRU Nancy-Brabois will be systematically proposed. At the end of this consultation, if the doctor deems it necessary, further investigations will be proposed and/or regular follow-up organised. Patients will be informed of this potential follow-up in pneumology before the questionnaire is given. There is no change in the usual follow-up of the population in case of non-reporting of functional respiratory signs.

The main criterion for judgement will be the frequency of functional respiratory signs (wheezing, dyspnea, cough, sputum) reported by IBD patients through an adapted self-report questionnaire.

If our hypothesis is confirmed, this will have direct practical consequences on the global and multidisciplinary management of IBD patients, in particular through a systematic search for chronic respiratory disease, which is currently under-researched in these patients.

This will improve the quality of life as well as the morbidity and mortality of our patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04225650
Study type Observational
Source Central Hospital, Nancy, France
Contact simon valentin, MD
Phone +33.83.15.70.24
Email S.VALENTIN@chru-nancy.fr
Status Not yet recruiting
Phase
Start date May 1, 2020
Completion date August 2020

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