A Phase 4 interventional study of Tapering of inhaled corticosteroid (ICS) treatment in Asthma, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Prevention
Background: Asthma is a common chronic condition characterized by respiratory symptoms and hyperresponsive airways. According to treatment guidelines, patients with persistent asthma require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS treatment. In the present study, asthma patients treated with ICS and exhibiting low levels of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized 1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to investigate whether patients with non-eosinophilic asthma can sustain their level of disease control during ICS tapering.
Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering in patients with non-eosinophilic asthma.
Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65 years, 3) ICS treatment equivalent to Budesonide 800 microg daily or more with at least 80% adherence, 4) Serum-periostin \< 50 ng/ml, 5) FeNO\<25 ppb at all prior visits, 6) Blood-eosinophils\<0.15 at screening, 7) no allergic asthma history, 8) no daily smoking within 6 months, 9) no other respiratory disease, 10) no daily treatment with immunosuppressives, 11) no pregnancy, and 12) no history of drug or alcohol abuse.
Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin, change in FEV1, change in blood-eosinophils.
Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110 patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16, 26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8. All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at screening and at week 8 and 16.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 20 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual care. Unchanged asthma medication during the entire study period.
Tapering of ICS over 8 weeks. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.
Drug: Tapering of inhaled corticosteroid (ICS) treatment
Tapering of ICS treatment over 8 weeks. Follow-up over 52 weeks in total. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.
Also known as: budesonide, fluticasone proprionate, mometasone furoate, beclometasone dipropionate, ciclesonide
Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS
Time frame: 52 weeks
Time from baseline to drop-out
Time frame: 52 weeks
Change in FeNO
Time frame: 52 weeks
Change in FEV1
Time frame: 52 weeks
Change in blood eosinophils
Time frame: 52 weeks
Change in serum periostin
Time frame: 52 weeks
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Hvidovre University Hospital