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

Renaud Louis

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Other: Step-down

Study type

Interventional

Funder types

Other

Identifiers

NCT02169323

2014-001316-19 (EudraCT Number)

2014-98

Details and patient eligibility

About

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.

Full 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"

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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