NCT01224951

Brief Summary

The main objectives of the study are:

  1. 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. 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. 3.these subgroups have different responses to anti-inflammatory treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

October 18, 2010

Last Update Submit

February 5, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • sputum cytokine mRNA levels

    6 and 10 weeks

Secondary Outcomes (1)

  • steroid-responsiveness

    6 and 10 weeks

Study Arms (2)

Qvar 100

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).

Drug: Beclomethasone

Control

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.

Interventions

BeclomethasoneDRUG

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.

Also known as: Qvar 100
Qvar 100

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • steroid naive asthmatics

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Dominique MA Bullens, MD, PhD

    Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

    PRINCIPAL INVESTIGATOR

  • Sven F Seys, MSc

    Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

January 1, 2011

Primary Completion

February 1, 2015

Study Completion

July 1, 2018

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

BE(1)