An interventional study of Change to dose of patient's regular medication in Asthma, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Other
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 9 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
All included patients underwent dose reduction.
Drug: Change to dose of patient's regular medication
Dose reduction of the drug each patient was already taking
Responsiveness to metacholine bronchial challenge
PD(20) if positive test
Time frame: 8 weeks
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
Plan to share: No
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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