Step-down of Inhaled Corticosteroids (ICS) in Non-eosinophilic Asthmatics

May 10, 2017 updated by: Renaud Louis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For patients whose asthma is not controlled at the beginning of the study, a step-up of the treatment is planned to the step 4 of Global Initiative for Asthma (GINA). This step-up will last for 3 months and will permit to ensure that these patients achieve the best possible level of asthma control. A progressive step-down of the inhaled corticosteroids (ICS) will then be achieved.

For patients whose asthma is controlled at the beginning of the study, a progressive step-down of the ICS will be directly achieved.

The progressive step-down of the ICS dose will be undertaken every 3 months according to the dose levels defined by GINA guidelines (from high to low daily dose) until a complete cessation of the ICS for 6 months. Other associated asthma treatment of asthma will be kept unchanged.

At each quarterly visit, a clinical composite outcome will be measured, for each patient. This composite outcome includes the score of asthma control questionnaire (ACQ) and the number of exacerbations. This outcome will determine at each visit if patients continue the study (success criterion) or stop the study (failure criterion). The success criterion is defined in the section "Current Primary Outcome"

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • University Hospital of Liege

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Step-down
Step-down of the inhaled corticosteroid (ICS) dose
Other: Step-down
Step-down of the inhaled corticosteroid (ICS) dose until discontinuation for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Up to 12 months to reach a 6 month stop of ICS

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 Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the frequency of self-reported adverse event of inhaled therapy for asthma
Time Frame: Every 3 months during the study (up to 15 months)
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
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the asthma control measured by the Asthma Control Questionnaire (ACQ)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the asthma control measured by the Asthma Control Test (ACT)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the asthma related quality of life by the mini-Asthma Quality of Life Questionnaire (miniAQLQ)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of lung function measured by percentage of predicted Forced Expiratory Volume in 1 second (%FEV1)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of lung function measured by Forced Expiratory Volume in 1 second (FEV1) divided by Forced Vital Capacity (FVC)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of lung function measured by reversibility to Short Acting Beta2-Agonists (SABA)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of inflammatory blood markers : blood cell count, fibrinogen, C-Reactive Protein (CRP)
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of sputum markers of inflammation : rates of neutrophils, eosinophils, macrophages, lymphocytes, epithelial cells
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the number of moderate exacerbations, defined as the number of visits to an emergency room, the number of unscheduled doctor or pneumologist visits, and increases in reliever use
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Evolution of the score of ICQ-S ("Inhaled Corticosteroids side-effect Questionnaire")
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)
Check of the inhalation technique
Time Frame: Every 3 months during the study (up to 15 months)
Every 3 months during the study (up to 15 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renaud Louis

Investigators

  • Principal Investigator: Renaud Louis, MD-PhD, University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 27, 2017

Study Completion (Actual)

February 27, 2017

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-98
  • 2014-001316-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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