ISRCTN70810039进行中（未招募）3 期
A pragmatic proof of concept study to evaluate the effect of dupilumab on mannitol challenge in severe asthma with type 2 inflammation
niversity of Dundee0 个研究点目标入组 20 人开始时间: 2022年4月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients, aged 18 to 75 years with severe GINA defined asthma
- •2. Taking a medium to high dose of ICS/LABA OR high dose ICS with another second line
- •controller (BDP equivalent dose of =800µg) of step 4/5 GINA therapy.
- •3. Established diagnosis of persistent asthma for at least 6 months according to GINA guidelines.
- •4. Diagnosis should have been properly documented at the screening visit, based on medical documentation and medical history.
- •5. Uncontrolled asthma as per ACQ6 =1.5
- •6. Forced Expiratory Volume in 1 second (FEV1) =50% predicted at screening.
- •7. Mannitol PD10 =635mg at Visit 1
- •8. Severe asthma with type 2 inflammation as evidenced by:
- •8.1. Eos =300 cells/µl at screening visit or within 6 months prior to screening OR
- •8.2. Eos =150 cells/µl with FeNO =25 ppb at screening visit or within 6 months prior to screening OR
- •8.3. FeNO =50 ppb at screening visit or within 6 months prior to screening
- •8.4. Eosinophil count and FeNO are not inclusion criteria in those patients already taking
- •maintenance oral corticosteroids prior to trial recruitment
- •9. Ability to give informed consent.
- •10. Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s wellbeing.
排除标准
- •1. Patient who has taken any biologic treatment for asthma within 3 months before V1.
- •2. Any other respiratory diseases such as COPD and moderate to severe bronchiectasis which in the opinion of the investigator are considered to be clinically significant and may have an impact on the study outcomes. Patients with Asthma COPD Overlap (ACO) may be included providing they meet all the other criteria.
- •3. Active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
- •4. Any known systemic (e.g., blood, liver, kidney, etc.) clinically significant medical condition, known significant laboratory abnormalities or communicable disease that may endanger the health or safety of the patient.
- •5. Asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month prior to screening visit or 3 months if hospital admission was required.
- •6. Any disorder that is not stable in the opinion of the Investigator.
- •7. Patients who are participating in the clinical phase of another interventional trial or have done so within the last 30 days or within 5 half-lives of the previous administered product (whichever is longer) before screening. Individuals who are participating in the follow-up
- •phase of another interventional trial, or who are enrolled in an observational study, will be co-enrolled where the Coordinating Investigator of each study agree that it is appropriate.
- •8. Female patients who are pregnant or lactating.
- •9. Patients unable or unwilling to consent.
- •10. Patients taking non-permitted medications.
- •11. Patients with a history of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the investigator contraindicates the patient's participation.
研究者
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