Clinical trial NCT03141424: Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
Official title: Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS
timeFrame: 52 weeks
measure: Time from baseline to drop-out
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in FeNO
timeFrame: 52 weeks
measure: Change in FEV1
timeFrame: 52 weeks
measure: Change in blood eosinophils
timeFrame: 52 weeks
measure: Change in serum periostin
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Respiratory Research Unit, Copenhagen University Hospital Hvidovre
Study officials:
References: