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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 :
This study includes two visits to 48 hours apart.
During the first visit :
During the second visit :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rheological measurement of sputum | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expectoration and measurement of sputum rheological properties | Other |
|
| 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) |
| 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 |
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Inclusion Criteria of healthy volunteers:
Exclusion Criteria of healthy volunteers:
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:
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:
Inclusion Criteria of patients with asthma:
- diagnosis of asthma confirmed by a Pulmonologist
Exclusion Criteria of patients with COPD:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique - INSERM 1406 | Grenoble | Isere | 38043 | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |