Plain English Summary
Background and study aims
Cystic fibrosis (CF) is an inherited disease that affects the internal organs, mainly the lungs and digestive system, by forming thick mucus plugs. Chronic pulmonary infections by the bacteria Pseudomonas aeruginosa (P. aeruginosa) are the main cause of mortality in CF patients. The specific biofilm mode of growth of P. aeruginosa in the CF-mucus enables this bacterium to escape the host immune system and currently available anti-microbial therapies and airway clearance techniques. Standard airway clearance techniques consist of autogenic drainage. A new technique is intrapulmonary percussive ventilation (IPV), in which chest physical therapy is administered to the airways by a pneumatic device that delivers percussive bursts into the lungs in certain frequencies (100-300, up to 900bpm). Research at the Belgian Nuclear Research Centre (SCKCEN) showed that cultivation in a low fluid shear environment induced a P. aeruginosa biofilm phenotype similar to that in CF, while cultivation in a higher fluid shear did not support development of this CF phenotype. The main goal of this study is to investigate the influence of fluid shear on the P. aeruginosa biofilm in CF patients using IPV.
Who can participate?
Patients with CF (age greater than 6 years) who are hospitalised 3 to 4 times a year during 10 days or routine IV antibiotic treatment. Patients must be able to produce sputum. We will compare the patients who are infected with Pseudomonas aeruginosa (patient group), to those who are not infected (control group).
What does the study involve?
For each study participant, three different physiotherapy regimens will be tested during three different hospitalisation periods: autogenous drainage, IPV low frequency (200 bpm) and IPV high frequency (400 bpm). In the patient group we will analyse sputum samples for P. aeruginosa characteristics before and after the different physiotherapy regimens. This study will be performed blind which means that the researcher who analyses the samples in the lab will not be informed of the therapeutic group to which the patient belongs.
What are the possible benefits and risks of participating?
All treatments adopted during this clinical trial are routinely used by CF patients and have been proven to be safe. Consequently, this study does not involve any risk for the patient. New insights gained from this study will improve the understanding of bacterial behaviour following exposure to high shear treatment in vivo and will be applied to a purposive adaptation of the current treatment of cystic fibrosis patients.
Where is the study run from?
The CF reference centre at the University Hospital in Brussels (UZ Brussel), Belgium.
When is study starting and how long is it expected to run for?
Patient recruitment started in January 2012 and the study will run until January 2014.
Who is funding the study?
Belgian Cystic Fibrosis Association (BCFA) (Belgium)
Who is the main contact?
Dr. J. Willekens
julie.willekens@uzbrussel.be
Trial website
Contact information
Type
Scientific
Primary contact
Dr Julie Willekens
ORCID ID
Contact details
Laarbeeklaan 101
Jette
1090
Belgium
Julie.Willekens@uzbrussel.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BUN14320095387
Study information
Scientific title
Effect of intrapulmonary percussive ventilation on Pseudomonas aeruginosa biofilm formation and virulence
Acronym
Study hypothesis
Assuming that the lung mucus in cystic fibrosis (CF) patients is characterized by low fluid shear (as the main shear-causing factor, mucociliary clearance, is absent), we want to investigate the impact of increased fluid shear on P. aeruginosa growth features and virulence in vivo. For this purpose, we want to use intrapulmonary percussive ventilation (IPV) as this presumably increases fluid shear in the lungs.
Ethics approval
Medical Ethics Committee UZ Brussel, 01 December 2011, Reference number 2009/004
Study design
Randomised controlled single-blind cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cystic fibrosis / Pseudomonas aeruginosa biofilm / Intrapulmonary Percussive Ventilation (IPV)
Intervention
Three different physiotherapy regimens (each patient will have all 3 regimens with a 3-month interval):
1. Autogenous drainage
2. IPV low frequency (200 bpm)
3. IPV high frequency (400 bpm)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Analysis of P. aeruginosa abundance, physiology, virulence factors and gene expression on day 1, day 4 and day 10 of each hospitalisation.
Secondary outcome measures
Lung function values [Forced expiratory volume in the first one second (FEV1) and forced vital capacity (FVC)] on day 1 and day 10 of each hospitalisation.
Overall trial start date
01/01/2012
Overall trial end date
01/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. CF patients (diagnosis confirmed by sweat test)
2. Age greater than 6 years, upper age limit 60 years
3. Hospitalisation 3 to 4 times a year for routine intravenous (IV) antibiotic treatment
4. Clinically stable at time of study entry
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Lung transplantation
2. Massive hemoptysis
3. Pneumothorax
4. Pregnancy
5. Non-invasive and invasive ventilation
Recruitment start date
01/01/2012
Recruitment end date
01/01/2014
Locations
Countries of recruitment
Belgium
Trial participating centre
Laarbeeklaan 101
Jette
1090
Belgium
Sponsor information
Organisation
Belgian Cystic Fibrosis Association (BCFA) (Belgium)
Sponsor details
Avenue J. Borlé 12
Brussel
1160
Belgium
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Belgian Cystic Fibrosis Association (BCFA) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary