Trial document




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  DRKS00008786

Trial Description

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Title

Influence of Pseudomonas aeruginosa colonisation status on respiratory muscle function in adult Cystic Fibrosis patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cystic fibrosis (CF) is the most common autosomal-recessive congenital disorder with the highest mortality rate in Caucasian population. 1 in 2500 alive new-born infants is affected by CF in Germany. It impairs the function of every gland in the body as it is a multisystemic disorder. Clinically most important is the impairment of the lung and the digestive system.
Pulmonary function impairment develops because of deficient pulmonary secretion, chronic infections of the lung and progressive pulmonary obstruction. The median survival rate could be raised over the last decades and the prediction of median survival is now > 50 years of age for individuals born in 2000. Therefore the care for adult patients is of major importance.
Most CF-patients still die because of respiratory failure.
The progress of the disease was positively influenced in the last years and decades due to extensive research and therefore better care and therapy. Still there are scientific issues that are still to be researched which could improve the understanding of the disease and therefore could lead to new therapies.
Respiratory muscle function (diaphragm and accessory respiratory muscles) is of major importance for patients with lung diseases. Because CF manifests to a great extent on the lung there is a scientific interest in evaluating the respiratory muscle function in those patients. Some patients have a germ called “Pseudomonas aerugninosa” in their expectorate (“sputum”). It is hypothesized that this bacterium negatively influences the function of the lung and respiratory muscles because it causes more mucus. But so far there are no large clinical trials dealing with this issue in adult patients. Therefore the aim of this study is to evaluate the respiratory muscle function in adult CF-patients regarding the colonisation status of Pseudomonas aeruginosa. Patients will be evaluated in the course of their outpatient visit at the adult CF-outpatient clinic (Lungenklinik Cologne Merheim, Germany).
Testing procedures are similar to a lung function assessment. The tests are not burdensome (=non-invasive). On addition patients will get a lung function assessment, a standardised 6-minute walk test including capillary blood gas analysis and will complete a quality of life-questionnaire. All testing procedures (except the respiratory muscle testing) are part of the usual well established routine diagnostic tools but will be evaluated systematically in this study regarding the colonisation status of Pseudomonas aeruginosa. Data will be acquired and evaluated pseudonymised.

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Brief Summary in Scientific Language

Cystic fibrosis (CF) is the most common autosomal-recessive congenital disorder with the highest mortality rate in Caucasian population. 1 in 2500 alive new-born infants is affected by CF in Germany. It impairs the exocrine function of every glandula as it is a multisystemic disorder. Clinically most important is the impairment of the lung and the digestive system.
Pulmonary function impairment develops because of deficient pulmonary secretion, chronic infections of the lung and progressive pulmonary obstruction. The median survival rate could be raised over the last decades and the prediction of median survival is now > 50 years of age for individuals born in 2000. Therefore the care for adult patients is of major importance.
Most CF-patients still die because of respiratory failure.
The progress of the disease was positively influenced in the last years and decades due to extensive research and therefore better care and therapy. Still there are scientific issues that are still to be researched which could improve the understanding of the disease and therefore could lead to new therapies.
Respiratory muscle function (diaphragm and accessory respiratory muscles) is of major importance for patients with lung diseases. Because CF manifests to a great extent on the lung there is a scientific interest in evaluating the respiratory muscle function in those patients. Some patients have Pseudomonas aerugninosa in their sputum. It is hypothesized that this bacterium negatively influences the function of the lung and respiratory muscles because it causes more mucus. But so far there are no large clinical trials dealing with this issue in adult patients. Therefore the aim of this study is to evaluate the respiratory muscle function in adult CF-patients regarding the colonisation status of Pseudomonas aeruginosa. Patients will be evaluated in the course of their outpatient visit at the adult CF-outpatient clinic (Lungenklinik Cologne Merheim, Germany).
Testing procedures are similar to a lung function assessment. The tests are non-invasive. On addition patients will get a lung function assessment, a standardised 6-minute walk test including capillary blood gas analysis and will complete a quality of life-questionnaire. All testing procedures (except the respiratory muscle testing) are part of the usual well established routine diagnostic tools but will be evaluated systematically in this study regarding the colonisation status of Pseudomonas aeruginosa. Data will be acquired and evaluated pseudonymised.

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Organizational Data

  •   DRKS00008786
  •   2015/06/17
  •   [---]*
  •   yes
  •   Approved
  •   64/2015, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   cystic fibrosis
  •   E84.0 -  Cystic fibrosis with pulmonary manifestations
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Interventions/Observational Groups

  •   adult CF-patients will be evaluated on their respiratory muscle strength and function regarding their status of Pseudomonas aeruginosa infection
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

PTImus to evaluate the respiratory muscle work load and reserve regarding the status of Pseudomonas aeruginosa infection
(Evaluation of the infection status of Pseudomonas aeruginosa analogous to the Leeds-criteria, initially division in 4 groups:
1. chronic Pseudomonas aeruginosa infection (>50% positive sputum samples)
2. intermittent Pseudomonas aeruginosa infection ( ≤ 50% positive sputum samples)
3. no Pseudomonas aeruginosa (negative sputum samples in the last 12 months)
4. never had Pseudomonas aeruginosa infection)
Afterwards subsuming the 4 subgroups: group 1 and 2 to group A (“Pseudomonas-positive”), group 3 and 4 to group B (“Pseudomonas-negative”). The aim of this study is to evaluate in adult CF-patients whether a chronic infection with Pseudomonas aeruginosa reduces the respiratory muscle strength and impairs respiratory muscle function.
PTImus= pressure-time index of the respiratory muscles= (mean PI/PImax) x (ti/ttot),
where PI is airway pressure during inspiration, calculated as 5 x P0.1 x ti (ttot= total breathing cycle time; ti = inspiratory time)

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Secondary Outcome

• Pneumological assessment:
o Spirometry and Bodyplethysmography
o standardised 6-minute-walk test (including a.o. capillary blood gas analysis, pulsoxymetry, assessment of dyspnoe (BORG-Scale), measurement of walking distance (m))
o respiratory muscle testing: PImax, PEmax, P0.1, Sn Pna, Calculation of the specific respiratory impedance (P0.1*ti/VT (VT= tidal volume)); P0.1/PImax
o data on quality of life: assessment via the Cystic Fibrosis Questionnaire-Revised-(CFQ-R)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/07/20
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Underlying disease: Cystic fibrosis (diagnosis proven via sweat test and/or genetic assessment)
• Stable patient= no exazerbation in the last 30 days
• Signed consent form
• Age ≥ 18 years

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Exclusion Criteria

• last hospitalisation due to acute clinical worsening less than 1 months ago
• i.v.-antibiotics in the last 30 days
• status post lung transplantation
• Age < 18 years

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Addresses

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    • Klinken der Stadt Köln gGmbhLungenklinik Merheim
    • Mr.  Prof.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbHLungenklinik Merheim
    • Ms.  Dr.  Friederike  Magnet 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbHLungenklinik Merheim
    • Ms.  Dr.  Friederike  Magnet 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinken der Stadt Köln gGmbhLungenklinik Merheim
    • Mr.  Prof.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/11/12
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Trial Publications, Results and other Documents

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