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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01224964
Acronym
BioSput-Air
Enrollment
1
Registered
2010-10-20
Start date
2011-01-31
Completion date
2014-10-31
Last updated
2014-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthmatic Patients

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: 1. 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. 2. 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. 3. These subgroups have different responses to anti-leukotrienes.

Interventions

DRUGMontelukast

Montelukast, 10 mg

DRUGlong acting beta2 mimetic

ICS+long acting beta2 agonist: twice daily

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
sputum cytokine mRNA8 weeks

Secondary

MeasureTime frame
responsiveness to the medication8 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026