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Completed

NCT Number: NCT02682290

Assessment of Rheological Parameters of Human Sputum.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expectoration and measurement of sputum rheological properties

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: RHEOMUCO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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