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

NCT06252454 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-04-16

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Masaryk University

    collaborator OTHER
  • University Hospital Hradec Kralove

    lead OTHER

Principal Investigators

  • Vladimir Koblizek, PhD · head of department

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06252454 on ClinicalTrials.gov