Periostin-guided withdrawal of inhaled corticosteroids in patients withnon-eosinophilic asthma

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 110

Inclusion Criteria

- Astmapatients followed in the Respiratory Outpatient Ward, Hvidovre
Hospital.
- At least one of the following test suggestive for asthma, performed at
any time during the outpatient course:
o 1) FEV1-reversibility of at least 12% and 200 ml after administration
of bronkodilator or Prednisolon course.
o 2) positiv bronkialprovokation test, such as mannitol, or
- 3) peakflow (PF)- variation of at least 20% bedømt assessed during a
14-day period, measured twice daily and at asthmatic symptoms.
- Age 18-65 years
- Treated with ICS daily in doses equivalent to Budesonid 800 ?g 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 < 20 ppb at all prior visits
- Blood-eosinofils <0,15 at screening
- Signed informed consent
- Fertile women: negative U-HCG
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of allergic asthma
- Doctor-diagnosed pneumonia within 6 weeks prior to screening
- Daily smoking or former daily smoking
- Known other respiratory condition 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the present study is to investigate whether reduction<br>and withdrawal of ICS in Th2-low asthma patients will result in changes<br>in disease control;Secondary Objective: Not applicable;Primary end point(s): 1. Change in Control Questionnaire (ACQ) from baseline to post-tapered<br>ICS. Clinically significant change will be 0.5 points.<br>2. Time from baseline to drop-out.;Timepoint(s) of evaluation of this end point: 1. Week 0,4,8,12,16,26,52.<br>2. Single measurement at drop-out

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in FeNO<br>2. Change in Serum-Periostin.<br>3. Change in FEV1.<br>4. Change in Blood-eosinophils;Timepoint(s) of evaluation of this end point: 1. Week 0,4,8,12,16,26,52.<br>2. Week 0,8,16<br>3. Week 0,4,8,12,16,26,52.<br>4. Week 0,4,8,12,16,26,52.

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