A Phase 2/3 interventional study of Furosemide 40 mg and Levodropropizine in Dyspnea, sponsored by University Hospital Hradec Kralove. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by University Hospital Hradec Kralove · Phase 2/3, Interventional, and Other
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:
Participants will be given:
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.
681 studies on the registry are indexed under Dyspnea; 159 are open to participants now.
This study's planned enrollment of 102 is above the median of 48 across 447 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 14 are open to participants now.
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Subjects will inhale once 40 mg of furosemide for 23 minutes, next they will be monitored for an hour and then cross over will take place, the subjects will inhale placebo - saline for 23 minutes and another hour of monitoring and observation will take place. Lastly all subject will be given levodropropizine 1 ml (60mg) with last hour of monitoring and observation
Drug: Furosemide 40 mg · Drug: Levodropropizine
Subjects will inhale once placebo - saline for 23 minutes, next they will be monitored for an hour and then cross over will take place, the subjects will inhale 40 mg of furosemide for 23 minutes and another hour of monitoring and observation will take place. Lastly all subject will be given levodropropizine 1 ml (60mg) with last hour of monitoring and observation
Drug: Levodropropizine · Other: Placebo - saline
Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.
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
Also known as: Levopront
Placebo will be used as a comparator
Safety and tolerability of inhaled furosemide
Incidence of Treatment-Emergent Adverse Events (AE) will be measured and reported. Any deterioration of clinical status of the subject during the study procedure will be reported as AE, especially but not only bronchospasm, worsening of the dyspnea, hemodynamic deterioration and every other event requiring change of the treatment of the subject during the study procedures and within next 24 hours until follow up visit.
Time frame: 24 hour
To prove abilty of inhaled furosemide to alleviate dyspnea
Dyspnea severity will be measured using Visual Analogue Scale (range 0 - 100 meaning 0 no dyspnea at all, 100 worst dyspnea imaginable) before and one hour after each inhalation (furosemide, placebo) calculating the change of dyspnea severity on the scale (decrease of the value on scale meaning improvement of dyspnea)
Time frame: 226 minutes
To prove abilty of inhaled furosemide to alleviate dyspnea
Dyspnea severity will be measured using Borg dyspnea scale (range 0-10, meaning 0 no dyspnea at all, 10 worst dyspnea imaginable) before and one hour after each inhalation (furosemide, placebo) calculating the change of dyspnea severity on the scale (decrease of the value on scale meaning improvement of dyspnea)
Time frame: 226 minutes
To discover any additive effect of levodropropizine to alleviate dyspnea
Dyspnea severity will be measured using Visual Analogue Scale (range 0 - 100 meaning 0 no dyspnea at all, 100 worst dyspnea imaginable) the change of dyspnea severity on the scale will be calculated after adding levodropropizine (decrease of the value on scale meaning improvement of dyspnea)
Time frame: 226 minutes whole study, 60 minutes levodropropizine intervention
To discover any additive effect of levodropropizine to alleviate dyspnea
Dyspnea severity will be measured using Borg dyspnea scale (range 0-10, meaning 0 no dyspnea at all, 10 worst dyspnea imaginable) the change of dyspnea severity on the scale will be calculated after adding levodropropizine (decrease of the value on scale meaning improvement of dyspnea)
Time frame: 226 minutes whole study, 60 minutes levodropropizine intervention
Started Feb 2024 (actual). Primary completion is estimated for Dec 2024, 10 months after the start.
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This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Furosemide
University Hospital Hradec Kralove