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NCT02309229 Clinical Trial

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

Cystic Fibrosis Clinical Trial

— MucoSpuCo  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02309229
Other study ID # ML8808
Secondary ID S54884
Status Completed
Phase N/A
First received April 5, 2013
Last updated December 2, 2014
Start date December 2012
Est. completion date January 2014

Study information
Verified date December 2014
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University hospital Leuven Leuven Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Other pollution and symptoms/exacerbations 6 months No
Primary sputum colour evoluation as a predictor for exacerbation 6 months No
Secondary symptoms as a predictor for exacerbations 6 months No
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