Assessment of Rheological Parameters of Human Sputum. (RHEOMUCO)

Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.

This is a proof of concept study. The aim of this study is to assess a device measuring rheological properties of human sputum of four populations :

• 10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)
• 10 patients with asthma
• 10 patients with cystic fibrosis
• 10 healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Asthma; Cystic Fibrosis; COPD
• Intervention / Treatment: Other: Expectoration and measurement of sputum rheological properties

Detailed Description

This study includes two visits to 48 hours apart.

During the first visit :

• Patients with COPD or cystic fibrosis will have a spontaneous expectoration
• Then all study participants will have an induced expectoration with hypertonic salin solution (4.5%).

During the second visit :

• Patients with COPD or cystic fibrosis will have a spontaneous expectoration
• Then, patients with COPD, asthma and healthy volunteers will have an induced expectoration with hypertonic salin solution (4.5%). Patients with cystic fibrosis will have a spontaneous expectoration 1 hour after an RhDNAse nebulization.

A control spirometry will be perform before each expectoration and during induced expectoration if necessary.

All sputum sample collected will be homogenized and then divided into two equal volumes in order to perform two separate rheological measurements of 15 minutes.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Isere
    • Grenoble, Isere, France, 38043
      • Centre d'Investigation Clinique - INSERM 1406

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria of healthy volunteers:

• 18>BMI>29
• No smoker
• No acute disease in the previous month

Exclusion Criteria of healthy volunteers:

• asthma, COPD, cystic fibrosis
• contraindications for spirometry
• pregnant woman
• legal exclusion criteria

Inclusion Criteria of patients with cystic fibrosis:

- cystic fibrosis with bronchial disorder. Diagnosis confirmed by a reference center

Exclusion Criteria of patients with cystic fibrosis:

• Forced Expiratory Volume in 1 second (FEV1 ) ≤ 40%, contraindications for RhDNAse, patient with chronic impairment of lung function (PaO2<60 mmHg at rest). Patient who is unable to perform a spontaneous expectoration.
• case of acute exacerbation during the last month
• contraindications for spirometry
• pregnant woman
• legal exclusion criteria

Inclusion Criteria of patients with COPD:

- COPD with FEV1/Forced Vital Capacity (FVC) <70% after administration of a beta-2 agonist

Exclusion Criteria of patients with COPD:

• Patient with chronic impairment of lung function and/or FEV1≤ 40%. Patient who is unable to perform a spontaneous expectoration.
• case of acute exacerbation during the last month
• contraindications for spirometry
• pregnant woman
• legal exclusion criteria

Inclusion Criteria of patients with asthma:

- diagnosis of asthma confirmed by a Pulmonologist

Exclusion Criteria of patients with COPD:

• Patient with chronic impairment of lung function and/or FEV1≤ 50%.
• Very unstable Asthma
• case of acute exacerbation during the last month
• contraindications for spirometry
• pregnant woman
• legal exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: rheological measurement of sputum; patients with COPD and patient with cystic fibrosis will perform a spontaneous expectoration. Then all participants will have an induced expectoration with hypertonic salin solution.	Other: Expectoration and measurement of sputum rheological properties

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the rheological measurements of human sputum	The reproducibility will be assessed during the first visit (Day1). The two rheological measurements performed 15 minutes apart will be compared. Rheological measurements : elastic modulus G' at 0.7Hz, elastic modulus G' at 3Hz, viscous modulus G'' at 0.7Hz, viscous modulus G'' at 3Hz)	Day1 (at the first visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the rheological measurements of human sputum	Comparison between the average of the two rheological measurements preformed at the first visit (Day1) and the average of the two rheological measurements preformed at the second visit (day3) 48 hours later.	Day3 (48h00 after day1)
Feasibility of the rheological measurements	frequency of measurements failure	Day1 (at the first visit) and day3 (48h00 after day1)
Comparison of sputum rheological measurements between the four populations studied (healthy volunteers, Asthma, COPD, Cystic Fibrosis)		Day1 (at the first visit) and day3 (48h00 after day1)
Influence of two mucolytic treatments (hypertonic saline solution, RhDNAse) on rheological measurements of patient with cystic fibrosis	During the first visit (day1), for patients with cystic fibrosis: Comparison of rheological parameters before and after nebulization of saline solution. During second visit (day 3) for patients with cystic fibrosis: Comparison of rheological parameters before and after nebulization of 2.5 ml of RhDNAse.	Day1 (at the first visit) and day3 (48h00 after day1)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2016
• Primary Completion (Actual): July 4, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: SPUTUM; RHEOLOGY
• 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: 38RC14.444

Plan for Individual participant data (IPD)

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