Development and Validation of a Sputum Biomarker mRNA Pan... | NCT01224964

Studies
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

NCT01224964

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Last Update Posted

Oct 23, 2014Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Asthmatic Patients

Interventions

Montelukast
long acting beta2 mimetic

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

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 18, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

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

Oct 22, 2014

Last Update Posted Date

Oct 23, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dominque Bullens, 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

The main objectives of the study are:

1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists)

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.
These subgroups have different responses to anti-leukotrienes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Montelukast	Active Comparator		Drug: Montelukast
long-acting beta2-mimetic	Active Comparator		Drug: long acting beta2 mimetic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast	Drug	Montelukast, 10 mg	Montelukast
long acting beta2 mimetic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sputum cytokine mRNA		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
responsiveness to the medication		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)

Exclusion Criteria:

viral/fungal/bacterial infection +fever (<1 month)
asthma exacerbation (<3 months)
other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
cardiac patients using beta-blockers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique MA Bullens, MD,PhD	Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België	Principal Investigator
Sven F Seys, MSc	Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België	Study Director

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided