Asthma, COPD, Cystic Fibrosis
Conditions
Keywords
SPUTUM, RHEOLOGY
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.
Interventions
OTHERExpectoration and measurement of sputum rheological properties
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed