NCT06252454

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Dyspnea

Interventions

Type	Name	Description
DRUG	Furosemide 40 mg	Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.
DRUG	Levodropropizine	Levodropropizine will be used to block C fibers in the airways, to evaluate if this double block of C fibers will have any effect on lowering intensity of dyspnea sensation
OTHER	Placebo - saline	Placebo will be used as a comparator

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2024-02-09
• Last updated: 2024-04-16

Locations

1 site across 1 country: Czechia