Assessment of Rheological Parameters of Human Sputum. (RHEOMUCO)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Asthma; Cystic Fibrosis; COPD

Treatments: Other: Expectoration and measurement of sputum rheological properties

Study type: Interventional

Funder types: Other

Identifiers

NCT02682290

38RC14.444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

rheological measurement of sputum

Other group

Description:

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.

Treatment:

Other: Expectoration and measurement of sputum rheological properties