RHEology of the Pulmonary MUcus (RHEMU)

Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme

Patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study.

• A rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples.
• Another part will be done on frozen bronchial mucus samples

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchial Mucus in COPD and Cystic Fibrosis
• Intervention / Treatment: Biological: bronchial mucus collection

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment

Description

Inclusion Criteria:

• Male or female over 18 years of age.
• Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment (mucus from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations from the bronchial fibroscopy programme).

Exclusion Criteria:

• Patient being opposed to the use of his mucus samples and data for this research.
• Patient protected by law (guardianship or curatorship), subject deprived of liberty

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the rheology parameters studied	Establish operating protocols for obtaining reliable rheological measurements with a view to using them as biomarkers	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Grenoble Alps

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis
• Other Study ID Numbers: 38RC20.298; 2020-A02367-32 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No