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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01224951
First received: October 18, 2010
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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.

Condition Intervention
Asthma
Drug: Beclomethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • sputum cytokine mRNA levels [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • steroid-responsiveness [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
    We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Qvar 100

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).

Drug: Beclomethasone
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.
Other Name: Qvar 100
No Intervention: Control
Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • steroid naive asthmatics

Exclusion Criteria:

  • viral/bacterial/fungal infection +fever(<1month)
  • asthma exacerbation (<3months)
  • other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224951

Locations
Belgium
University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Dominique MA Bullens, MD, PhD Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Study Director: Sven F Seys, MSc Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
  More Information

No publications provided

Responsible Party: Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01224951     History of Changes
Other Study ID Numbers: Biomarker sputum airway study2
Study First Received: October 18, 2010
Last Updated: October 22, 2014
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Beclomethasone
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014