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Assessment of Rheological Parameters of Human Sputum. (RHEOMUCO)

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ClinicalTrials.gov Identifier: NCT02682290
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
COPD Asthma Cystic Fibrosis Other: Expectoration and measurement of sputum rheological properties Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.
Actual Study Start Date : March 3, 2016
Actual Primary Completion Date : July 4, 2017
Actual Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
rheological measurement of sputum

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.

Other: Expectoration and measurement of sputum rheological properties



Primary Outcome Measures :
  1. Reproducibility of the rheological measurements of human sputum [ Time Frame: Day1 (at the first visit) ]

    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 :
  1. Reproducibility of the rheological measurements of human sputum [ Time Frame: Day3 (48h00 after day1) ]
    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.

  2. Feasibility of the rheological measurements [ Time Frame: Day1 (at the first visit) and day3 (48h00 after day1) ]
    frequency of measurements failure

  3. 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) ]
  4. Influence of two mucolytic treatments (hypertonic saline solution, RhDNAse) on rheological measurements of patient with cystic fibrosis [ Time Frame: Day1 (at the first visit) and day3 (48h00 after day1) ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682290


Locations
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France
Centre d'Investigation Clinique - INSERM 1406
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02682290     History of Changes
Other Study ID Numbers: 38RC14.444
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
SPUTUM
RHEOLOGY

Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases