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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cystic Fibrosis

Keywords

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sputum colour cystic fibrosis pollution

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cystic fibrosis patients

patients with cystic fibrosis

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Lieven Dupont

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lieven J Dupont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University hospital Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S54884

Identifier Type: OTHER

Identifier Source: secondary_id

ML8808

Identifier Type: -

Identifier Source: org_study_id