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

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Asthmatic Patients

Treatments: Drug: Montelukast; Drug: long acting beta2 mimetic

Study type: Interventional

Funder types: Other

Identifiers

NCT01224964

Biomarker sputum airway study3

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

Montelukast

Active Comparator group

Treatment:

Drug: Montelukast

long-acting beta2-mimetic

Active Comparator group

Treatment:

Drug: long acting beta2 mimetic