2024-514672-41-00招募中2 期
The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Advanced Respiratory Diseases (INFURO)
Fakultni Nemocnice Hradec Kralove1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年8月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Safety and tolerability of a single dose of inhaled furosemide assessed as the incidence and nature of all reported treatment-related adverse events.
研究概览
简要总结
Validation of the safety and tolerability of inhaled furosemide in patients with dyspnea.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Ability to understand the essence of the study and express consent to the study by signing the Informed Consent form
- •The patient's ability to assess dyspnea on the visual-analog scale (VAS) and on the Borg scale
- •The presence of lung disease (asthma, chronic obstructive pulmonary disease, interstitial lung disease, oncological disease with lung involvement, patients with dyspnea after COVID19, drug-induced dyspnea, lung infection) leading to acute or chronic dyspnea, which will currently be screened for the study assessed by the patient on the visual analog scale (VAS) with a value of 50 points and more and/or on the Borg scale with a value of 5 points and more
- •In the case of a woman of childbearing age, consent to abstain from sexual intercourse for the duration of participation in the study (i.e. for the duration of hospitalization). Note For evaluation purposes, menarche is considered to be the beginning of childbearing age, and the end is considered to be the end of the 12th month of amenorrhea from the last menstruation (menopause) at the usual age for the physiological cessation of ovarian function.
排除标准
- •Hypersensitivity to the medicinal substance or to any auxiliary substance of furosemide or levodropropizine
- •The presence of COVID-19, if it is not possible to ensure that all study activities are carried out in isolation from other patients, including entries in the source and study documentation, meeting the currently valid hygiene regulations
- •Hypersensitivity to sulfonamides (e.g. to sulfonylurea derivatives or to sulfonamide antibiotics)
- •Severe hypokalemia
- •Severe hyponatremia
- •Hypovolemia and with or without hypotension
- •Dehydration
- •Disorder of mucociliary clearance (Kartagener's syndrome, ciliary dyskinesia)
- •Severe liver disorders in Child Pugh stage B – C cirrhosis
- •Renal insufficiency with clearance < 35 ml/min
- •Unstable patient requiring frequent changes or adjustments in medication and treatment
- •Patients on continuous i.v. medication or with the need to adjust therapy more than once every 4 hours
- •Ineligibility to participate in all study procedures
- •Pregnancy, breastfeeding
- •Participation in another clinical trial involving the administration of an investigational medicinal product within 28 days (or 5 half-lives, whichever is longer) prior to screening
结局指标
主要结局
Safety and tolerability of a single dose of inhaled furosemide assessed as the incidence and nature of all reported treatment-related adverse events.
Safety and tolerability of a single dose of inhaled furosemide assessed as the incidence and nature of all reported treatment-related adverse events.
次要结局
- The effect of examined substances to suppress dyspnoea will be evaluated by changing to a visually analog scale (VAS) and the Borg scale. Changes on both steps will be evaluated statistically at the level of 5% probability and it will be determined whether the changes have achieved minimum clinically relevant changes against the default values. As a minimum clinically relevant change is considered 1 point in the Brog scale and 10 mm in VAS.
研究者
Michal Švarc
Scientific
Fakultni Nemocnice Hradec Kralove
研究点 (1)
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