Sputum Purulence as a Predictor of Cystic Fibrosis Exacer... | NCT02309229

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

NCT02309229

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Dec 5, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S54884	Other Identifier	UZ Leuven

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Apr 5, 2013

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Lieven Dupont, Prof. Dr., Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Cystic fibrosis patients		patients with cystic fibrosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sputum colour evoluation as a predictor for exacerbation		6 months

Secondary Outcomes

Measure	Description	Time Frame
symptoms as a predictor for exacerbations		6 months

Other Outcomes

Measure	Description	Time Frame
pollution and symptoms/exacerbations		6 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of cystic fibrosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lieven J Dupont, MD, PhD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Leuven		Leuven	Vlaams-Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided