Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01224951

Acronym

BioSput-Air

Enrollment

Registered

2010-10-20

Start date

2011-01-31

Completion date

2018-07-31

Last updated

2018-02-06

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

Conditions

Asthma

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 (inhaled corticosteroids) 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.

Interventions

DRUGBeclomethasone

400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* steroid naive asthmatics

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
sputum cytokine mRNA levels	6 and 10 weeks

Secondary

Measure	Time frame	Description
steroid-responsiveness	6 and 10 weeks	We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores

Countries

Belgium

Outcome results

None listed

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