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Analysis of the Pseudomonas aeruginosa biofilm in the respiratory samples of cystic fibrosis patients
ISRCTN ISRCTN75391385
DOI 10.1186/ISRCTN75391385
ClinicalTrials.gov identifier
EudraCT number
Public title Analysis of the Pseudomonas aeruginosa biofilm in the respiratory samples of cystic fibrosis patients
Scientific title Effect of intrapulmonary percussive ventilation on Pseudomonas aeruginosa biofilm formation and virulence
Acronym N/A
Serial number at source BUN14320095387
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.
Lay 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
Ethics approval Medical Ethics Committee UZ Brussel, 01 December 2011, Reference number 2009/004
Study design Randomised controlled single-blind cross-over trial
Countries of recruitment Belgium
Disease/condition/study domain Cystic fibrosis / Pseudomonas aeruginosa biofilm / Intrapulmonary Percussive Ventilation (IPV)
Participants - 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
Participants - exclusion criteria 1. Lung transplantation
2. Massive hemoptysis
3. Pneumothorax
4. Pregnancy
5. Non-invasive and invasive ventilation
Anticipated start date 01/01/2012
Anticipated end date 01/01/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 10
Interventions 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)
Primary outcome measure(s) Analysis of P. aeruginosa abundance, physiology, virulence factors and gene expression on day 1, day 4 and day 10 of each hospitalisation.
Secondary outcome measure(s) 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.
Sources of funding Belgian Cystic Fibrosis Association (BCFA) (Belgium)
Trial website
Publications
Contact name Dr  Julie  Willekens
  Address Laarbeeklaan 101
  City/town Jette
  Zip/Postcode 1090
  Country Belgium
  Email Julie.Willekens@uzbrussel.be
Sponsor Belgian Cystic Fibrosis Association (BCFA) (Belgium)
  Address Avenue J. Borlé 12
  City/town Brussel
  Zip/Postcode 1160
  Country Belgium
  Sponsor website: http://www.muco.be
Date applied 21/12/2012
Last edited 06/02/2013
Date ISRCTN assigned 06/02/2013
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