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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Non-cystic Fibrosis Bronchiectasis

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabent
    • Leuven, Vlaams-Brabent, Belgium, 3000
      • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

non-cystic fibrosis bronchiectasis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess predictive value of sputum colour chart to evaluate airway inflammation	Airway inflammation will be assessed by analysis of sputum differential cell counts and cytokine/chemokine analysis in sputum.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Link the degree of airway inflammation to the proteolytic activity of sputum enzymes.	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.	10 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (ESTIMATE): February 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Fibrosis; Bronchiectasis; Inflammation; Pneumonia
• Other Study ID Numbers: B32220084152 (Belgium: Institutional Review Board); B51060 (OTHER: Belgium: Institutional Review Board)