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

Completed

• Conditions: Healthy; Non-cystic Fibrosis Bronchiectasis

• Registration Number: NCT01792440
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2010-07
• Study Completion: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Link the degree of airway inflammation to the proteolytic activity of sputum enzymes.	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.

Trial Locations

Locations (1)

University Hospital Leuven; 🇧🇪 Leuven, Vlaams-Brabent, Belgium