Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
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.