Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity

Bispebjerg Hospital9 enrolled

Overview

An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.

We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects. This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control. After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Change to dose of patient's regular medicationDRUG

Dose reduction of the drug each patient was already taking

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Physician-diagnosed asthma for at least 6 months * Fulfill ERS/ATS giudelines for severe asthma * Stable dose of ICS for at least 4 weeks * Able to carry out study procedures * Negative metacholine provocation test at screening * Negative reversibility to beta agonist at screening * FeNO under 50 ppb Exclusion Criteria: * Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months * FEV1 under 70% of predicted * Acute upper or lower airway infection requiring antibiotics in the last 4 weeks * Exacerbation of asthma requiring prednisolone in the last 6 months * Current smoking * Pregnancy or breastfeeding * Other clinically significant lung disease * Current participation in another interventional study

Locations (1)

Lungemedicinsk Forskningsenhed

Copenhagen, Denmark

Outcomes

Primary Outcomes

Responsiveness to metacholine bronchial challenge

PD(20) if positive test

Time frame: 8 weeks

Secondary Outcomes

ACQ score

asthma control questionnaire

Time frame: 8 weeks

miniAQLQ score

asthma quality of life score

Time frame: 8 weeks

Pulmonary function tests

FEV1, FVC, reversibility to beta agonist

Time frame: 8 weeks

FeNO

fraction of exhaled nitric oxide

Time frame: 8 weeks

Sputum cell differentials

sputum neutrophil and eosinophil counts

Time frame: 8 weeks

Data from ClinicalTrials.gov

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