Prevalence of Respiratory Impairment During IBD

Asthma Clinical Trial

— PARAMICI  

Official title:

Assessing the Prevalence of Respiratory Impairment in Chronic Inflammatory Bowel Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04225650
• Other study ID #: 2019PI164
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: August 2020

Study information

• Verified date: December 2019
• Source: Central Hospital, Nancy, France
• Contact: simon valentin, MD
• Phone: +33.83.15.70.24
• Email: S.VALENTIN[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with IBD (Crohn disease or Ulcerative colitis) between January 1990 and December 2019.

• Consultation in the Hepato-Gastroenterology Department of the CHRU Nancy-Brabois

• Patients who received full information about the research organization and did not object to the use of the data.

• Patients over 18 years of age

Exclusion Criteria:

• Inability to complete the questionnaire

• Diagnosis of IBD uncertain

• Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code :Pregnant, parturient or breastfeeding mother, Minor person, person who is subject to a legal protection measure

• Unable to express consent

• Persons deprived of their liberty by a judicial or administrative decision,

• Persons under psychiatric care (articles L. 3212-1 and L. 3213-1)

Related Conditions & MeSH terms

• Asthma
• Bronchiectasis
• Chronic Obstructive Pulmonary Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Other:
• Pulmonology consultation
In case of functional respiratory signs, a consultation with a pulmonologist will be booked. At the end of this consultation, if the doctor deems it necessary, other investigations will be proposed and/or regular follow-up will be organised.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	University of Lorraine

References & Publications (4)

Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. Review. — View Citation

Rodriguez-Roisin R, Bartolome SD, Huchon G, Krowka MJ. Inflammatory bowel diseases, chronic liver diseases and the lung. Eur Respir J. 2016 Feb;47(2):638-50. doi: 10.1183/13993003.00647-2015. Epub 2016 Jan 21. Review. — View Citation

Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1. Review. — View Citation

Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of functional respiratory signs	Frequency of functional respiratory signs (wheezing, dyspnea, coughing, sputum) reported by IBD patients	Through study completion, an average of 6 months
Secondary	Chronic respiratory diseases	Frequency of chronic respiratory diseases (asthma, COPD, respiratory allergies) among IBD patients	Through study completion, an average of 6 months
Secondary	Exacerbations	Frequency of reported exacerbations of chronic respiratory diseases in IBD patients.	Through study completion, an average of 6 months
Secondary	Drugs	Frequency of use of respiratory tropic drugs by IBD patients	Through study completion, an average of 6 months