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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Terminated

CT.gov ID

NCT01224964

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objectives of the study are:

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.

Condition or Disease	Intervention/Treatment	Phase
Asthmatic Patients	Drug: Montelukast Drug: long acting beta2 mimetic	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Montelukast	Drug: Montelukast Montelukast, 10 mg
Active Comparator: long-acting beta2-mimetic	Drug: long acting beta2 mimetic ICS+long acting beta2 agonist: twice daily

Arm

Intervention/Treatment

Active Comparator: Montelukast

Drug: Montelukast

Montelukast, 10 mg

Active Comparator: long-acting beta2-mimetic

Drug: long acting beta2 mimetic

ICS+long acting beta2 agonist: twice daily

Outcome Measures

Primary Outcome Measures

sputum cytokine mRNA [8 weeks]

Secondary Outcome Measures

responsiveness to the medication [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01224964

Other Study ID Numbers:

Biomarker sputum airway study3

First Posted:

Oct 20, 2010

Last Update Posted:

Oct 23, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Asthma

Montelukast

Study Results

No Results Posted as of Oct 23, 2014