Assessment of Rheological Parameters of Human Sputum.

University Hospital, Grenoble45 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

COPD Asthma Cystic Fibrosis

Interventions

Expectoration and measurement of sputum rheological propertiesOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre d'Investigation Clinique - INSERM 1406

Grenoble, Isere, France

Outcomes

Primary Outcomes

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)

Time frame: Day1 (at the first visit)

Secondary Outcomes

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.

Time frame: Day3 (48h00 after day1)

Feasibility of the rheological measurements

frequency of measurements failure

Time frame: 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)

Time frame: 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.

Time frame: Day1 (at the first visit) and day3 (48h00 after day1)

Data from ClinicalTrials.gov

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