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The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis

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ClinicalTrials.gov Identifier: NCT01792440
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 20, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven

Brief Summary:
Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The investigators' aim was to study the relevance of clinical parameters in terms of underlying disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis bronchiectasis population.

Condition or disease
Non-cystic Fibrosis Bronchiectasis Healthy

Detailed Description:
Patients from the non-cystic fibrosis bronchiectasis (NCFB) outpatient clinic were recruited in our study from September 2009 till July 2010. Control healthy subjects were recruited among peers of the patient or hospital staff during the same period. For the NCFB patients, underlying etiologies of NCFB and Pseudomonas aeruginosa (PA) colonization status were analyzed and each patient was evaluated by means of spirometry (FVC and FEV1), Leicester Cough Questionnaire (LCQ) and Sputum Colour Chart (SCC). SCC assessment was both done by letting the patient predict his sputum purulence prior to sputum induction and by SCC scoring after sputum harvest by the physician.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Sputum Colour Chart as a Predictor of Lung Inflammation, Proteolysis and Damage in Non-cystic Fibrosis Bronchiectasis
Study Start Date : September 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2012

Group/Cohort
non-cystic fibrosis bronchiectasis
patients with non-cystic fibrosis bronchiectasis will be evaluated cross-sectionally
healthy control subjects
healthy control subjects will be evaluated cross-sectionally



Primary Outcome Measures :
  1. Assess predictive value of sputum colour chart to evaluate airway inflammation [ Time Frame: 10 months ]
    Airway inflammation will be assessed by analysis of sputum differential cell counts and cytokine/chemokine analysis in sputum.


Secondary Outcome Measures :
  1. Link the degree of airway inflammation to the proteolytic activity of sputum enzymes. [ Time Frame: 10 months ]
    Proteolytic activity of sputum enzymes (total gelatinolytic activity) and sputum enzymes (neutrophil elastase, MMP9) will be quantified in sputum supernatant of NCFB patients and controls.


Biospecimen Retention:   Samples With DNA
induced sputum cells


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
non-cystic fibrosis bronchiectasis
Criteria

Inclusion Criteria:

  • Diagnosis of NCFB, based on CT findings of bronchiectatic disease in the absence of cystic fibrosis (CF) as a cause.
  • stable

Exclusion Criteria:

  • no recent exacerbation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792440


Locations
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Belgium
University Hospital Leuven
Leuven, Vlaams-Brabent, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Study Director: Pieter Goeminne, MD Universitaire Ziekenhuizen Leuven

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Responsible Party: Dr. Lieven Dupont, prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01792440    
Other Study ID Numbers: B32220084152
B51060 ( Other Identifier: Belgium: Institutional Review Board )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Bronchiectasis
Pneumonia
Fibrosis
Inflammation
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections