Assessment of Rheological Parameters of Human Sputum.

Not Applicable

Completed

• Conditions: COPD; Cystic Fibrosis; Asthma
• Interventions: Other: Expectoration and measurement of sputum rheological properties

• Registration Number: NCT02682290
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Study Start: 2016-03-03
• Primary Completion: 2017-07-04
• Study Completion: 2017-07-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rheological measurement of sputum	Expectoration and measurement of sputum rheological properties	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.

Primary Outcome Measures

Name	Time	Method
Reproducibility of the rheological measurements of human sputum	Day1 (at the first visit)	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)

Secondary Outcome Measures

Name	Time	Method
Reproducibility of the rheological measurements of human sputum	Day3 (48h00 after day1)	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.
Feasibility of the rheological measurements	Day1 (at the first visit) and day3 (48h00 after day1)	frequency of measurements failure
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	Day1 (at the first visit) and day3 (48h00 after day1)	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.

Trial Locations

Locations (1)

Centre d'Investigation Clinique - INSERM 1406; 🇫🇷 Grenoble, Isere, France