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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: Change to dose of patient's regular medication

• Registration Number: NCT03321877
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-26
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Change to dose of patient's regular medication	All included patients underwent dose reduction.

Primary Outcome Measures

Name	Time	Method
Responsiveness to metacholine bronchial challenge	8 weeks	PD(20) if positive test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lungemedicinsk Forskningsenhed; 🇩🇰 Copenhagen, Denmark