Clinical trial NCT02682290: Assessment of Rheological Parameters of Human Sputum.
Official title: Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Asthma
Cystic Fibrosis
Keywords: SPUTUM
RHEOLOGY
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reproducibility of the rheological measurements of human sputum
timeFrame: Day1 (at the first visit)
Secondary outcomes:
measure: Reproducibility of the rheological measurements of human sputum
timeFrame: Day3 (48h00 after day1)
measure: Feasibility of the rheological measurements
timeFrame: Day1 (at the first visit) and day3 (48h00 after day1)
measure: Comparison of sputum rheological measurements between the four populations studied (healthy volunteers, Asthma, COPD, Cystic Fibrosis)
timeFrame: Day1 (at the first visit) and day3 (48h00 after day1)
measure: Influence of two mucolytic treatments (hypertonic saline solution, RhDNAse) on rheological measurements of patient with cystic fibrosis
timeFrame: Day1 (at the first visit) and day3 (48h00 after day1)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre d'Investigation Clinique - INSERM 1406
state: Isere
Study officials:
References: