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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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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

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Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The subjects and investigators as well as care provider will not know the order of the studied substances given to subjects.

Study Groups

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Furosemide

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

Group Type EXPERIMENTAL

Furosemide 40 mg

Intervention Type DRUG

Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.

Levodropropizine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Levodropropizine

Intervention Type DRUG

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

Placebo - saline

Intervention Type OTHER

Placebo will be used as a comparator

Interventions

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Furosemide 40 mg

Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.

Intervention Type 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

Intervention Type DRUG

Placebo - saline

Placebo will be used as a comparator

Intervention Type OTHER

Other Intervention Names

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Levopront

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No