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

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ClinicalTrials.gov Identifier: NCT02309229
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven

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

Condition or disease
Cystic Fibrosis

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Sputum Purulence as a Predictor of Cystic Fibrosis Exacerbations: a Prospective Cohort Trial.
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort
Cystic fibrosis patients
patients with cystic fibrosis



Primary Outcome Measures :
  1. sputum colour evoluation as a predictor for exacerbation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. symptoms as a predictor for exacerbations [ Time Frame: 6 months ]

Other Outcome Measures:
  1. pollution and symptoms/exacerbations [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of cystic fibrosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309229


Locations
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Belgium
University hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Lieven J Dupont, MD, PhD Universitaire Ziekenhuizen Leuven

Additional Information:

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Responsible Party: Dr. Lieven Dupont, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02309229     History of Changes
Other Study ID Numbers: ML8808
S54884 ( Other Identifier: UZ Leuven )
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven:
sputum colour
cystic fibrosis
pollution
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases