The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Advanced Respiratory Diseases (INFURO) - INFURO_2023

Fakultni Nemocnice Hradec Kralove0 个研究点目标入组 114 人开始时间: 2024年6月28日最近更新: 2024年8月21日

试验速览

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•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.

•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

发起方

Fakultni Nemocnice Hradec Kralove