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Clinical Trial Summary

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


Clinical Trial Description

102 subjects from the pool of patients hospitalized in our pulmonary clinics will be randomized in 1:1 ratio to 2 arms in double blinded manner. Subjects in both arms will inhale first vial of study medication - furosemide 40 mg or placebo (saline). Dyspnea severity and vital functions will be measured, adverse reactions will be monitored. After an hour the subjects will inhale the second vial of study medication followed by the same procedure as earlier. Neither subjects, nor investigators will know which vial contains furosemide and which contains placebo. At last all subjects will receive levodropropizine open label and the dyspnea severity, vital signs and adverse reaction will be monitored for another hour. The measured values will be statistically evaluated a results published. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06252454
Study type Interventional
Source University Hospital Hradec Kralove
Contact Michal Svarc, MD
Phone +420 495 834 771
Email michal.svarc@fnhk.cz
Status Recruiting
Phase Phase 2/Phase 3
Start date February 27, 2024
Completion date December 2025

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