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Completed

NCT Number: NCT02309229

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

Completed

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. sputum colour evoluation as a predictor for exacerbation

    Time frame: 6 months

Secondary outcomes

  1. symptoms as a predictor for exacerbations

    Time frame: 6 months

Other outcomes

  1. pollution and symptoms/exacerbations

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: MucoSpuCo

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 5, 2014
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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