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Assessment of Rheological Parameters of Human Sputum. (RHEOMUCO)

Primary Purpose

COPD, Asthma, Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Expectoration and measurement of sputum rheological properties
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD focused on measuring SPUTUM, RHEOLOGY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre d'Investigation Clinique - INSERM 1406

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

rheological measurement of sputum

Arm 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Feasibility of the rheological measurements
frequency of measurements failure
Comparison of sputum rheological measurements between the four populations studied (healthy volunteers, Asthma, COPD, Cystic Fibrosis)
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.

Full Information

First Posted
January 27, 2016
Last Updated
October 25, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02682290
Brief Title
Assessment of Rheological Parameters of Human Sputum.
Acronym
RHEOMUCO
Official Title
Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 3, 2016 (Actual)
Primary Completion Date
July 4, 2017 (Actual)
Study Completion Date
July 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Asthma, Cystic Fibrosis
Keywords
SPUTUM, RHEOLOGY

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rheological measurement of sputum
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Expectoration and measurement of sputum rheological properties
Primary Outcome Measure Information:
Title
Reproducibility of the rheological measurements of human sputum
Description
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)
Time Frame
Day1 (at the first visit)
Secondary Outcome Measure Information:
Title
Reproducibility of the rheological measurements of human sputum
Description
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.
Time Frame
Day3 (48h00 after day1)
Title
Feasibility of the rheological measurements
Description
frequency of measurements failure
Time Frame
Day1 (at the first visit) and day3 (48h00 after day1)
Title
Comparison of sputum rheological measurements between the four populations studied (healthy volunteers, Asthma, COPD, Cystic Fibrosis)
Time Frame
Day1 (at the first visit) and day3 (48h00 after day1)
Title
Influence of two mucolytic treatments (hypertonic saline solution, RhDNAse) on rheological measurements of patient with cystic fibrosis
Description
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.
Time Frame
Day1 (at the first visit) and day3 (48h00 after day1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centre d'Investigation Clinique - INSERM 1406
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Rheological Parameters of Human Sputum.

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