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

December 2, 2014 updated by: Dr. Lieven Dupont, Universitaire Ziekenhuizen KU Leuven
To use the sputum colour chart as a predictor for cystic fibrosis exaerbations

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of cystic fibrosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cystic fibrosis patients
patients with cystic fibrosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
symptoms as a predictor for exacerbations
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
pollution and symptoms/exacerbations
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Lieven J Dupont, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML8808
  • S54884 (Other Identifier: UZ Leuven)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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