Lungemedicinsk Forskningsenhed
Copenhagen, 2400, Denmark
NCT Number: NCT03321877
An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Copenhagen, 2400, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose reduction of the drug each patient was already taking
Time frame: 8 weeks
PD(20) if positive test
Time frame: 8 weeks
asthma control questionnaire
Time frame: 8 weeks
asthma quality of life score
Time frame: 8 weeks
FEV1, FVC, reversibility to beta agonist
Time frame: 8 weeks
fraction of exhaled nitric oxide
Time frame: 8 weeks
sputum neutrophil and eosinophil counts
Bispebjerg Hospital
Other
Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?
Acronym: DOSIS
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