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

NCT ID: NCT01792440

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Non-cystic Fibrosis Bronchiectasis; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

non-cystic fibrosis bronchiectasis

patients with non-cystic fibrosis bronchiectasis will be evaluated cross-sectionally

No interventions assigned to this group

healthy control subjects

healthy control subjects will be evaluated cross-sectionally

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lieven Dupont

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pieter Goeminne, MD

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospital Leuven

Leuven, Vlaams-Brabent, Belgium

Countries

Belgium

Other Identifiers

B51060

Identifier Type: OTHER

Identifier Source: secondary_id

B32220084152

Identifier Type: -

Identifier Source: org_study_id