Assessment of Rheological Parameters of Human Sputum.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COPD, Asthma, Cystic Fibrosis

Intervention / Treatment
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* Other: Expectoration and measurement of sputum rheological properties


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: rheological measurement of sputum<br>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<br> <br> |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPUTUM, RHEOLOGY