NCT02169323

Brief Summary

There is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled corticosteroids (ICS) than eosinophilic asthmatics. As non-eosinophilic asthmatic patients are treated by ICS according to international guidelines for asthma, the investigators would like to investigate whether stepping-down of ICS in these patients may be safe. Indeed, the investigators can reasonably expect that a progressive cessation of ICS is possible in some of these patients without any clinical worsening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jun 2014

Typical duration for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

June 18, 2014

Last Update Submit

May 10, 2017

Conditions

Asthma

Keywords

Non-eosinophilic AsthmaInhaled corticosteroidsStep-down

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients meeting the success criterion at each visit until the end of the study (corresponding to a discontinuation of the treatment by inhaled corticosteroids (ICS) for 6 months)

    The success criterion is defined at each visit as: \- An Asthma Control Questionnaire (ACQ) score lower than 1.5 or a variation of the ACQ score from baseline smaller than 0.5 AND \- A number of severe exacerbations from the start of the step-down smaller or equal to the number of severe exacerbations in the previous year

    Up to 12 months to reach a 6 month stop of ICS

Secondary Outcomes (15)

  • Evolution of the number of severe exacerbations, defined as use of systemic corticosteroids during at least 3 days or hospitalizations or emergency visits due to asthma with use of systemic corticosteroids

    Every 3 months during the study (up to 15 months)

  • Evolution of the frequency of self-reported adverse event of inhaled therapy for asthma

    Every 3 months during the study (up to 15 months)

  • Evolution of treatment compliance measured by the Mediation Adherence Report Scale (MARS) and by pharmacy records

    Every 3 months during the study (up to 15 months)

  • Evolution of the asthma control measured by the Asthma Control Questionnaire (ACQ)

    Every 3 months during the study (up to 15 months)

  • Evolution of the asthma control measured by the Asthma Control Test (ACT)

    Every 3 months during the study (up to 15 months)

  • +10 more secondary outcomes

Study Arms (1)

Step-down

EXPERIMENTAL

Step-down of the inhaled corticosteroid (ICS) dose

Other: Step-down

Interventions

Step-downOTHER

Step-down of the inhaled corticosteroid (ICS) dose until discontinuation for 6 months

Step-down

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • Physician-diagnosed asthma based on the presence of typical symptoms (wheezing, breathlessness, chest tightness, cough)
  • Asthma confirmed by:
  • Forced expiratory volume in 1 second (FEV1) increase of at least 12% and 200 mL after inhalation of 400 mcg salbutamol
  • And/or a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20M) less than 16 mg/ml
  • Sputum eosinophils rate less than 3%
  • Absolute blood eosinophils count less than 400 per mm3
  • Treatment with a stable dose of inhaled corticosteroid (ICS) for the previous three months

You may not qualify if:

  • High risk of asthma-related death, defined by:
  • Near-fatal asthma history, requiring a stay in an intensive care unit
  • Current using or recent discontinuation (four weeks) of oral corticosteroids (OCS)
  • Treatment with omalizumab
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liege

Liège, 4000, Belgium

Location

Related Publications (1)

  • Demarche S, Schleich F, Henket M, Paulus V, Louis R, Van Hees T. Step-down of inhaled corticosteroids in non-eosinophilic asthma: A prospective trial in real life. Clin Exp Allergy. 2018 May;48(5):525-535. doi: 10.1111/cea.13106. Epub 2018 Mar 6.

    PMID: 29383782DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Renaud Louis, MD-PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Pneumology Department

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 23, 2014

Study Start

June 1, 2014

Primary Completion

February 27, 2017

Study Completion

February 27, 2017

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

BE(1)