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

NCT06252454 | Recruiting Phase 2 DMC

• 2 other identifiers: INFURO_20232018-001298-26
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hour

Secondary Outcomes (4)

• To prove abilty of inhaled furosemide to alleviate dyspnea

  226 minutes

• To prove abilty of inhaled furosemide to alleviate dyspnea

  226 minutes

• To discover any additive effect of levodropropizine to alleviate dyspnea

  226 minutes whole study, 60 minutes levodropropizine intervention

• To discover any additive effect of levodropropizine to alleviate dyspnea

  226 minutes whole study, 60 minutes levodropropizine intervention

Study Arms (2)

Furosemide

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Furosemide 40 mg DRUG

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

Furosemide

Levodropropizine 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

Also known as: Levopront

Furosemide; Placebo

Placebo - saline OTHER

Placebo will be used as a comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead
• Masaryk University: collaborator

Study Sites (1)

Plicní klinika, Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

MeSH Terms

Conditions

Dyspnea

Interventions

Furosemide; dipropizine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Vladimir Koblizek, PhD

  head of department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Svarc, MD

CONTACT

+420 495 834 771; michal.svarc@fnhk.cz

Vladimir Koblizek, PhD

CONTACT

+420 495 834 771; vladimir.koblizek@fnhk.cz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The subjects and investigators as well as care provider will not know the order of the studied substances given to subjects.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 9, 2024
• Study Start: February 27, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CZ (1)