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Measurement of Viscoelastic Properties of Bronchopulmonary Secretions. (VLM-2)

Primary Purpose

Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Pulmonary Disease

Eligibility Criteria

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

Inclusion Criteria:

  • obstructive pulmonary disease

Exclusion Criteria:

  • none

Sites / Locations

  • Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient Group

Arm Description

Patients with obstructive pulmonary diseases receiving standard physiotherapy treatment

Outcomes

Primary Outcome Measures

Viscoelasticity
Evolution of elastic modulus, viscous modulus, phase angle and non-linear characteristics of lung secretions.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
November 2, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03888300
Brief Title
Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.
Acronym
VLM-2
Official Title
VLM-2: Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is experimental and aims to (a) compare the viscoelastic properties of bronchial secretions obtained in patients suffering from obstructive respiratory disease, and (b) to compare the viscoelastic properties of bronchial secretions obtained in patients before and after application of a respiratory physiotherapy or exercise as usually prescribed. After agreement, the sputum of the participants will be collected according to the method used in clinical routine.Experiments (collection and analysis of sputum) will be conducted at the Saint-Luc University Clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will receive standard physiotherapy as prescribed by the physician
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Group
Arm Type
Experimental
Arm Description
Patients with obstructive pulmonary diseases receiving standard physiotherapy treatment
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Chest Physiotherapy, physical exercises
Primary Outcome Measure Information:
Title
Viscoelasticity
Description
Evolution of elastic modulus, viscous modulus, phase angle and non-linear characteristics of lung secretions.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: obstructive pulmonary disease Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Reychler, PT, PhD
Phone
+3227642316
Email
gregory.reychler@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
William PONCIN, PT, PhD
Email
william.poncin@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reychler, PT, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Poncin
Phone
003227641633
Email
william.poncin@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.

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