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

Bispebjerg Hospital

Status: Completed

Conditions: Asthma

Treatments: Drug: Change to dose of patient's regular medication

Study type: Interventional

Funder types: Other

Identifiers

NCT03321877

55855

Details and patient eligibility

About

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

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Study group

Experimental group

Description:

All included patients underwent dose reduction.

Treatment:

Drug: Change to dose of patient's regular medication