Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/12/2012
Date assigned
06/02/2013
Last edited
06/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 (SCK•CEN) 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

http://www.muco.be

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

Publication citations

Additional files

Editorial Notes