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AsthmaPhase 4NCT02169323

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

A Phase 4 study testing Step-down in people with Asthma, run by Renaud Louis at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Step-down
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteBelgium
Study dates
Jun 2014to 27 Feb 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital of Liege

    Liège, 4000

Other trials in Belgium

About this study

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.

Read the 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"

Conditions
Asthma
Being tested
Step-down
Keywords
Non-eosinophilic Asthma, Inhaled corticosteroids, Step-down
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Step-downOther

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

Study groups in NCT02169323
Study groupRoleWhat they receive
Step-downExperimentalStep-down of the inhaled corticosteroid (ICS) dose
Receives: Other: Step-down

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (15)

  1. 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

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

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

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

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

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

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

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

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

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

  6. Evolution of the asthma related quality of life by the mini-Asthma Quality of Life Questionnaire (miniAQLQ)

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

  7. Evolution of the Fractional Exhaled Nitric Oxide (FeNO)

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

  8. Evolution of lung function measured by percentage of predicted Forced Expiratory Volume in 1 second (%FEV1)

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

  9. Evolution of lung function measured by Forced Expiratory Volume in 1 second (FEV1) divided by Forced Vital Capacity (FVC)

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

  10. Evolution of lung function measured by reversibility to Short Acting Beta2-Agonists (SABA)

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

  11. Evolution of inflammatory blood markers : blood cell count, fibrinogen, C-Reactive Protein (CRP)

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

  12. Evolution of sputum markers of inflammation : rates of neutrophils, eosinophils, macrophages, lymphocytes, epithelial cells

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

  13. 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

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

  14. Evolution of the score of ICQ-S ("Inhaled Corticosteroids side-effect Questionnaire")

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

  15. Check of the inhalation technique

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion27 Feb 2017
  4. Study completion27 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02169323
Sponsor's protocol ID
2014-98
Other IDs
2014-001316-19, 2014
Status last verified
May 2017
First submitted
18 Jun 2014
Last updated
11 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29383782

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Step-down in people with Asthma, run by Renaud Louis at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02169323, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.

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