Development of a sputum biomarker panel to diagnose different types of asthma

Development and validation of a sputum biomarker mRNA panel for the diagnostic work-up of asthma - biosput-air study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000924-14-BE

Enrollment

Registered

2011-03-16

Start date

2011-05-23

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

asthma

Interventions

Trade Name: Qvar Pharmaceutical Form: Inhalation powder INN or Proposed INN: BECLOMETASONE DIPROPIONATE CAS Number: 08/09/5534 Current Sponsor code: 194 IS 76 F 11 Other descriptive name: qvar Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: steroid naive asthmatics Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: viral/bacterial/fungal infection +fever(<1month) asthma exacerbation (<3months) other airway diseases (CF, ciliary dyskinesia, bronchiectasis)

Design outcomes

Primary

Measure	Time frame
Main Objective: to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids) ;Secondary Objective: 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. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group. 3)These subgroups have different responses to anti-inflammatory treatment. ;Primary end point(s): sputum cytokine mRNA levels;Timepoint(s) of evaluation of this end point: at baseline, after 6 and 10 weeks of treatment	—

Measure

Time frame

Main Objective: to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids) ;Secondary Objective: 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. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group. 3)These subgroups have different responses to anti-inflammatory treatment. ;Primary end point(s): sputum cytokine mRNA levels;Timepoint(s) of evaluation of this end point: at baseline, after 6 and 10 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): lung function characteristics asthma questionnaires;Timepoint(s) of evaluation of this end point: at baseline, after 6 and 10 weeks of treatment	—

Countries

Belgium

Contacts

Public ContactSven Seys

KU Leuven

sven.seys@med.kuleuven.be003216346165

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026