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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001298-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Masaryk University | OTHER |
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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:
Participants will be given:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide 40 mg | Drug | Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Svarc, MD | Contact | +420 495 834 771 | michal.svarc@fnhk.cz | |
| Vladimir Koblizek, PhD | Contact | +420 495 834 771 | vladimir.koblizek@fnhk.cz |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Koblizek, PhD | head of department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plicní klinika, Fakultni nemocnice Hradec Kralove | Recruiting | Hradec Králové | 50005 | Czechia |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| C035916 | dipropizine |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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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
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The subjects and investigators as well as care provider will not know the order of the studied substances given to subjects.
| 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 |
|
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| Placebo - saline | Other | Placebo will be used as a comparator |
|
| 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 |
| 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 |
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |