NL-OMON45521
已完成
不适用
A pRospective, multicenter, single-arm study EvaLuating the safety and feasIbility of Targeted Lung Denervation (TLD) for the trEatment of severe asthma. - RELIEF 1
VAIRA, Inc0 个研究点目标入组 10 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Asthma
- 发起方
- VAIRA, Inc
- 入组人数
- 10
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Adult; age \*21 to \*65;
- •2\. Patient has provided written informed consent using a form that has been reviewed and
- •approved by the Ethics Committee;
- •3\. Diagnosis of severe asthma as defined by the 2017 GINA Report, and are taking regular maintenance medication that includes: a) Inhaled corticosteroid (ICS) at a dosage \>1000\*g beclomethasone per day or equivalent, AND b) Long\-acting \*\-agonist (LABA) at a dosage of \*100\*g Salmeterol per day or equivalent (MDI prn); \-or\- a) Inhaled corticosteroid (ICS) at a dosage \>1000\*g beclomethasone per day or equivalent, AND b) Leukotriene receptor antagonist (LTRA) or theophylline; And may be taking other add\-on medications including (but not limited to): \* Tiotropium; \*Oral corticosteroids (OCS) at a dosage of \*10mg per day. Note: Subjects on a dosage regimen of 20mg OCS every other day may be included as this averages to a daily dose of 10mg.
- •4\. Pre\-bronchodilator FEV1 \*60% predicted on stable therapy after a 4\-week medication run\-in of an inhaled corticosteroid (\>1000\*g beclomethasone per day or equivalent) and a long\-acting \*\-agonist (\*100 \*g Salmeterol per day or equivalent MDI prn);
- •5\. Subject has at least two days of asthma symptoms during the 4\-weeks of the Baseline Diary Period;
- •6\. Women of child bearing potential must have a negative pregnancy test (serum or urine) at screening and agree not to become pregnant for the duration of the study;
- •7\. Non\-smoker for at least 6 months (if former smoker, less than 10 pack years total smoking history) and agree to continue not smoking for duration of the study;
- •8\. Patient is a candidate for bronchoscopy in the opinion of the physician or per hospital
- •guidelines;
排除标准
- •1\. In the 24 months prior to enrollment, the subject has:
- •\* Been intubated for asthma
- •\* Had intensive Care Unit admission(s) for asthma
- •\* Been treated with immunosuppressant therapy for any reason (steroids excluded)
- •2\. In the 12 months prior to enrollment, the subject has had:
- •\* \* 3 lower respiratory tract infections requiring antibiotics
- •\* \* 3 hospitalizations for asthma exacerbations
- •3\. In the 3 months prior to enrollment, the subject has taken/used an opioid(s)
- •4\. In the 6 weeks prior to enrollment the subject had a lower respiratory tract infection or
- •asthma exacerbation that required:
结局指标
主要结局
未指定
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