NCT02309229

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

April 5, 2013

Last Update Submit

December 2, 2014

Conditions

Cystic Fibrosis

Keywords

sputum colourcystic fibrosispollution

Outcome Measures

Primary Outcomes (1)

  • sputum colour evoluation as a predictor for exacerbation

    6 months

Secondary Outcomes (1)

  • symptoms as a predictor for exacerbations

    6 months

Other Outcomes (1)

  • pollution and symptoms/exacerbations

    6 months

Study Arms (1)

Cystic fibrosis patients

patients with cystic fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of cystic fibrosis

You may qualify if:

  • a diagnosis of cystic fibrosis
  • Pseudomonas aeruginosa colonization
  • at least 2 exacerbations in the previous year
  • at least 18 years of age

You may not qualify if:

  • colour blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Lieven J Dupont, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 5, 2013

First Posted

December 5, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

BE(1)