Sputum Purulence as a Predictor of Cystic Fibrosis Exacerbations: a Prospective Cohort Trial.

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT02309229
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

To use the sputum colour chart as a predictor for cystic fibrosis exaerbations

Detailed Description

Patients will score their sputum purulence daily using three colour charts. They will also score for respiratory and other symptoms.

Primary analysis will focus on the predicting value of sputum purulence on exacerbations. Secondary analysis will evaluate symptoms on exacerbation prediction. A third subanalysis will focus on correlation of daily pollution fluctuations and sputum purulence or symptoms.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-05
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-02
• Last Update Submitted: 2014-12-02
• Study First Posted: 2014-12-05
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• a diagnosis of cystic fibrosis
• Pseudomonas aeruginosa colonization
• at least 2 exacerbations in the previous year
• at least 18 years of age

Exclusion Criteria

• colour blindness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sputum colour evoluation as a predictor for exacerbation	6 months

Secondary Outcome Measures

Name	Time	Method
symptoms as a predictor for exacerbations	6 months

Trial Locations

Locations (1)

University hospital Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium