EUCTR2017-002244-33-DK进行中（未招募）1 期
Periostin-guided withdrawal of inhaled corticosteroids in patients withnon-eosinophilic asthma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Astmapatients followed in the Respiratory Outpatient Ward, Hvidovre
- •- 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
- •- 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
排除标准
- •- 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
研究者
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