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


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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2013

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.

Arms, Groups and Cohorts

  • Cystic fibrosis patients
    • patients with cystic fibrosis

Clinical Trial Outcome Measures

Primary Measures

  • sputum colour evoluation as a predictor for exacerbation
    • Time Frame: 6 months

Secondary Measures

  • symptoms as a predictor for exacerbations
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Lieven Dupont, Prof. Dr. – Universitaire Ziekenhuizen Leuven
  • Overall Official(s)
    • Lieven J Dupont, MD, PhD, Principal Investigator, Universitaire Ziekenhuizen Leuven

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