This trial is active, not recruiting.

Condition asthma
Treatment beclomethasone
Sponsor Universitaire Ziekenhuizen Leuven
Start date January 2011
End date February 2015
Trial size 40 participants
Trial identifier NCT01224951, Biomarker sputum airway study2


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Patients will be randomized to receive either the active arm (3/4) or a SABA as rescue medication (1/4). The patient will be asked to take Qvar 100 (2puffs) in the morning and in the evening. Daily dose (400 microgram).
beclomethasone Qvar 100
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.
(No Intervention)
Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar.

Primary Outcomes

sputum cytokine mRNA levels
time frame: 6 and 10 weeks

Secondary Outcomes

time frame: 6 and 10 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - steroid naive asthmatics Exclusion Criteria: - viral/bacterial/fungal infection +fever(<1month) - asthma exacerbation (<3months) - other airway diseases (CF, ciliary dyskinesia, bronchiectasis)

Additional Information

Official title Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
Principal investigator Dominique MA Bullens, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.