Assessment of Rheological Parameters of Human Sputum.

Asthma Clinical Trial

— RHEOMUCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682290
• Other study ID #: 38RC14.444
• Status: Completed
• Phase: N/A
• First received: January 27, 2016
• Last updated: October 25, 2017
• Start date: March 3, 2016
• Est. completion date: July 4, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 4, 2017
• Est. primary completion date: July 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis

Intervention

Other:
• Expectoration and measurement of sputum rheological properties

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique - INSERM 1406	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Feasibility of the rheological measurements	frequency of measurements failure	Day1 (at the first visit) and day3 (48h00 after day1)
Secondary	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)
Secondary	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)