The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases

INFURO_2023

The goal of this monocentric double blinded cross over trial is to evaluate safety and tolerability of inhaled furosemide in patients with pulmonary diseases and dyspnea. The main question\[s\] it aims to answer are: * is inhaled furosemide safe and well tolerated? * is inhaled furosemide capable of dyspnea suppression and is there any additive effect of levodropropizine Participants will be given: * inhaled furosemide or placebo in double blinded cross over manner. Dyspnea severity and vital functions will be measured, adverse reactions monitored * all participants will receive levodropropizine open label. Dyspnea severity and vital functions will be measured, adverse reactions monitored

2024-02-27

2024-12-01

2025-12-01

Recruiting

Early phase I

102

Inclusion Criteria: * ability to understand and sing written consent * ability to use visual analogue (VAS) and Borg dyspnea scale * presence of lung disease (asthma, chronic obstructive pulmonary disease, interstitial pulmonary disease, tumour affecting lungs, Coronavirus Disease 2019 (COVID19), drug induced dyspnea, lung infection) * dyspnea at least 50 points in VAS and at least 5 point in Borg dyspnea scale * women of childbearing age consent ot avoid sexual intercourse during the study participation Exclusion Criteria: * hypersensitivity to furosemide, levodropropizine or any additives in studied drugs * mucociliary disorder (kartegener syndrome, ciliary dyskinesis) * severe liver disease - cirrhosis Child Pugh B or C * renal failure, creatinine clearance less than 35 ml/min * unstable patient requiring frequent treatment changes * patients with continual intravenous medication requiring modification of their therapy more often than ever 4 hours * unability to participate in all study procedures * pregnancy, breast feeding * participation in other clinical trial with administration of study drug in last 28 days or 5 half times of studied drug (the longer period is taken into account) before screening

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Two arms. Subjects in both arms will get first inhalation of furosemide or placebo in double blinded order. After cross over the subjects will get placebo instead of furosemide and vice versa. Lastly all subjects will get unblinded levodropropizine', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The subjects and investigators as well as care provider will not know the order of the studied substances given to subjects.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 102, 'type': 'ESTIMATED'}}

2024-04-16