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

NCT ID: NCT02169323

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-02-27

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Step-down

Step-down of the inhaled corticosteroid (ICS) dose

Group Type: EXPERIMENTAL

Step-down

Intervention Type: OTHER

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

Interventions

Step-down

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renaud Louis

OTHER

Sponsor Role: lead

Responsible Party

Renaud Louis

Head of the Pneumology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Renaud Louis, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

University Hospital of Liege

Liège, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 29383782 (View on PubMed)

Other Identifiers

2014-001316-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2014-98

Identifier Type: -

Identifier Source: org_study_id