Clinical trial NCT06252454: The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases
Official title: The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Dyspnea
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2024-02-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of inhaled furosemide
timeFrame: 24 hour
Secondary outcomes:
measure: To prove abilty of inhaled furosemide to alleviate dyspnea
timeFrame: 226 minutes
measure: To prove abilty of inhaled furosemide to alleviate dyspnea
timeFrame: 226 minutes
measure: To discover any additive effect of levodropropizine to alleviate dyspnea
timeFrame: 226 minutes whole study, 60 minutes levodropropizine intervention
measure: To discover any additive effect of levodropropizine to alleviate dyspnea
timeFrame: 226 minutes whole study, 60 minutes levodropropizine intervention
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: Plicní klinika, Fakultni nemocnice Hradec Kralove
Study officials:
affiliation: head of department
name: Vladimir Koblizek, PhD
role: PRINCIPAL_INVESTIGATOR
References: