Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma

NCT ID: NCT03141424

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-10-25

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Usual care. Unchanged asthma medication during the entire study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B

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.

Group Type: EXPERIMENTAL

Tapering of inhaled corticosteroid (ICS) treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

budesonide; fluticasone proprionate; mometasone furoate; beclometasone dipropionate; ciclesonide

Eligibility Criteria

Inclusion Criteria

• Astma patients followed in the Respiratory Outpatient Ward, Hvidovre Hospital, Amager Hospital or Glostrup Hospital.
• At least one of the following test suggestive for asthma, performed at any time during the outpatient course: 1) FEV1-reversibility on at least 12% and 200 ml after administration of bronchodilator or Prednisolon course, 2) positive bronchial provocation test, such as mannitol, 3) peakflow (PF)-variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms, or 4) Variability in FEV1 on at least 12% and 200 ml
• Age 18-65 years
• Treated with ICS daily in doses equivalent to Budesonide 800 microg daily or more
• ICS adherence of at least 80% during the last year, assessed from used prescriptions
• Serum-periostin < 50 ng/ml at screening (8)
• FeNO < 25 ppb at all prior visits
• Blood-eosinophils <0,15 at screening
• Signed informed consent

Exclusion Criteria

• History of allergic asthma
• Doctor-diagnosed pneumonia within 6 weeks prior to screening
• Daily smoking or former daily smoking within the last 6 months
• Known other respiratory conditions such as COPD or pulmonary sarcoidosis
• Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor
• Pregnancy or planned pregnancy
• Abuse of alcohol or other recreational drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christiane Mosbech

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Respiratory Research Unit, Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Countries

Denmark

References

Mosbech CH, Godtfredsen NS, Ulrik CS, Westergaard CG. Biomarker-guided withdrawal of inhaled corticosteroids in asthma patients with a non-T2 inflammatory phenotype - a randomized controlled trial study protocol. BMC Pulm Med. 2023 Oct 4;23(1):372. doi: 10.1186/s12890-023-02679-y.

Reference Type: DERIVED

PMID: 37794472 (View on PubMed)

Other Identifiers

Asthmaperiostin

Identifier Type: -

Identifier Source: org_study_id