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

Dyspnea Clinical Trial

— INFURO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252454
• Other study ID #: INFURO_2023
• Secondary ID: 2018-001298-26
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 27, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University Hospital Hradec Kralove
• Contact: Michal Svarc, MD
• Phone: +420 495 834 771
• Email: michal.svarc[@]fnhk.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• Furosemide 40 mg
Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.
• 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

Locations

Country	Name	City	State
Czechia	Plicní klinika, Fakultni nemocnice Hradec Kralove	Hradec Králové

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	226 minutes
Secondary	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)	226 minutes
Secondary	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)	226 minutes whole study, 60 minutes levodropropizine intervention
Secondary	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)	226 minutes whole study, 60 minutes levodropropizine intervention