Chronic Obstructive Pulmonary DiseasePARAMICINCT04225650
Prevalence of Respiratory Impairment During IBD
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Central Hospital, Nancy, France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Bronchiectasis
- What is being tested?
- Pulmonology consultation
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient followed for IBD in the hepato-gastroenterology department of the CHRU de Nancy may be eligible.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing the Prevalence of Respiratory Impairment in Chronic Inflammatory Bowel Diseases
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).
Read more
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.
Read the detailed 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Bronchiectasis, Inflammatory Bowel Diseases
- Being tested
- Pulmonology consultation
- Keywords
- Chronic Obstructive Pulmonary Disease, Asthma, Epidemiology, Inflammatory Bowel Diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Bronchiectasis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonology consultationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of functional respiratory signs
Frequency of functional respiratory signs (wheezing, dyspnea, coughing, sputum) reported by IBD patients
Measured: Through study completion, an average of 6 months
Secondary outcomes (3)
Chronic respiratory diseases
Frequency of chronic respiratory diseases (asthma, COPD, respiratory allergies) among IBD patients
Measured: Through study completion, an average of 6 months
Exacerbations
Frequency of reported exacerbations of chronic respiratory diseases in IBD patients.
Measured: Through study completion, an average of 6 months
Drugs
Frequency of use of respiratory tropic drugs by IBD patients
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 May 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225650
- Sponsor's protocol ID
- 2019PI164
- Acronym
- PARAMICI
- Status last verified
- Dec 2019
- First submitted
- 7 Jan 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
PubMed 17499605Torres 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.
PubMed 27914655Ungaro 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.
PubMed 27914657Rodriguez-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.
PubMed 26797027
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Prevalence of Respiratory Impairment in Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT04225650
- Acronym / sponsor ID
- PARAMICI / 2019PI164
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Bronchiectasis, Inflammatory Bowel Diseases
- Keywords
- Chronic Obstructive Pulmonary Disease, Asthma, Epidemiology, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 1 May 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 13 Jan 2020 (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.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient followed for IBD in the hepato-gastroenterology department of the CHRU de Nancy may be eligible.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonology consultationIn 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. | Other | – |
Primary outcome
Frequency of functional respiratory signs
Time frame: Through study completion, an average of 6 months
Frequency of functional respiratory signs (wheezing, dyspnea, coughing, sputum) reported by IBD patients
3 secondary outcomes
Chronic respiratory diseases
Time frame: Through study completion, an average of 6 months
Exacerbations
Time frame: Through study completion, an average of 6 months
Drugs
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Background: PubMed 17499605Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
- Background: PubMed 27914655Torres 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.
- Background: PubMed 27914657Ungaro 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.
- Background: PubMed 26797027Rodriguez-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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Central Hospital, Nancy, France.
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 4 inclusion and 6 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 simon valentin, MD (+33.83.15.70.24 ext. +0033, S.VALENTIN@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of functional respiratory signs (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225650, which also lists 4 linked publications.
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 15 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.