Furosemide for Dyspnea | Advanced lung disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Ability to understand the essence of the study and express consent to the study by signing the Informed Consent form\n- The patient's ability to assess dyspnea on the visual-analog scale (VAS) and on the Borg scale\n- 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\n- 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."}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to the medicinal substance or to any auxiliary substance of furosemide or levodropropizine\n- 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\n- Hypersensitivity to sulfonamides (e.g. to sulfonylurea derivatives or to sulfonamide antibiotics)\n- Severe hypokalemia\n- Severe hyponatremia\n- Hypovolemia and with or without hypotension\n- Dehydration\n- Disorder of mucociliary clearance (Kartagener's syndrome, ciliary dyskinesia)\n- Severe liver disorders in Child Pugh stage B – C cirrhosis\n- Renal insufficiency with clearance < 35 ml/min\n- Unstable patient requiring frequent changes or adjustments in medication and treatment\n- Patients on continuous i.v. medication or with the need to adjust therapy more than once every 4 hours\n- Ineligibility to participate in all study procedures\n- Pregnancy, breastfeeding\n- 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"}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability of a single dose of inhaled furosemide assessed as the incidence and nature of all reported treatment-related adverse events.","definition_or_measurement_approach":"Assessed as the incidence and nature of all reported treatment-related adverse events (i.e. frequency and characterization of adverse events related to treatment following a single dose of inhaled furosemide)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Dyspnoea suppression evaluated by change in Visual Analog Scale (VAS) and Borg scale; statistical evaluation at 5% significance. Minimum clinically relevant change defined as 1 point on Borg scale and 10 mm on VAS."}

Czechia

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

13-11-2025

Processing Time Days

541

Number Of Sites

1

Number Of Participants

114

Primary sponsor

Full Name

Fakultni Nemocnice Hradec Kralove

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"Czechia","full_name":"Masarykova Univerzita","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6,8","organisation_type":"Educational Institution"}