DyspneaPhase 2/3INFURONCT06252454
The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases
A Phase 2/3 study testing Furosemide 40 mg and Levodropropizine in people with Dyspnea, run by University Hospital Hradec Kralove at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Furosemide 40 mg and Levodropropizine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Feb 2024to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Plicní klinika, Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
Vladimír Koblížek, Doc., PhD, +420495834771, vladimir.koblizek@fnhk.cz
Vladimír Koblížek, Doc, PhD
About this study
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
Read the 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.
- Conditions
- Dyspnea
- Being tested
- Furosemide 40 mg, Levodropropizine, Placebo - saline
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 40 mgDrug
Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.
LevodropropizineDrug
Also called Levopront
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 - salineOther
Placebo will be used as a comparator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Levodropropizine; Other: Placebo - saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hour
Secondary outcomes (4)
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)
Measured: 226 minutes
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)
Measured: 226 minutes
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)
Measured: 226 minutes whole study, 60 minutes levodropropizine intervention
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)
Measured: 226 minutes whole study, 60 minutes levodropropizine intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start27 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
- Investigators
- Vladimir Koblizek, PhD, Principal investigator, head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252454
- Sponsor's protocol ID
- INFURO_2023
- Other IDs
- 2018-001298-26, 2018
- Acronym
- INFURO
- Status last verified
- Apr 2024
- First submitted
- 2 Jan 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases
- ClinicalTrials.gov ID
- NCT06252454
- Acronym / sponsor ID
- INFURO / INFURO_2023
- Conditions
- Dyspnea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Drug: Furosemide 40 mg, Drug: LevodropropizineSubjects 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 |
| Placebo | Placebo comparator | Drug: Levodropropizine, Other: Placebo - salineSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide 40 mgFurosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea. | Drug | Furosemide |
| LevodropropizineAlso: LevoprontLevodropropizine 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 | Drug | Furosemide, Placebo |
| Placebo - salinePlacebo will be used as a comparator | Other | Placebo |
Primary outcome
Safety and tolerability of inhaled furosemide
Time frame: 24 hour
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.
4 secondary outcomes
To prove abilty of inhaled furosemide to alleviate dyspnea
Time frame: 226 minutes
To prove abilty of inhaled furosemide to alleviate dyspnea
Time frame: 226 minutes
To discover any additive effect of levodropropizine to alleviate dyspnea
Time frame: 226 minutes whole study, 60 minutes levodropropizine intervention
To discover any additive effect of levodropropizine to alleviate dyspnea
Time frame: 226 minutes whole study, 60 minutes levodropropizine intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Koblizek, PhD principal investigator
head of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Furosemide 40 mg and Levodropropizine in people with Dyspnea, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Svarc, MD (+420 495 834 771, michal.svarc@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of inhaled furosemide (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.