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

About this trial
This is an interventional treatment trial for Obstructive Pulmonary Disease
Eligibility Criteria
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
NCT ID
NCT03888300
First Posted
March 20, 2019
Last Updated
November 2, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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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