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

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

Detailed Description
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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.

Official Title
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Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?

Conditions
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Asthma

Intervention / Treatment
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* Drug: Change to dose of patient's regular medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All included patients underwent dose reduction. | Drug: Change to dose of patient's regular medication<br>* Dose reduction of the drug each patient was already taking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responsiveness to metacholine bronchial challenge | PD(20) if positive test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACQ score | asthma control questionnaire | 8 weeks | 
| miniAQLQ score | asthma quality of life score | 8 weeks | 
| Pulmonary function tests | FEV1, FVC, reversibility to beta agonist | 8 weeks | 
| FeNO | fraction of exhaled nitric oxide | 8 weeks | 
| Sputum cell differentials | sputum neutrophil and eosinophil counts | 8 weeks |