The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases
NCT06252454 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2024-04-16
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
Interventions
- DRUG
-
Furosemide 40 mg
Furosemide will be used to block C fibers in the lungs, thus lowering intensity of sensation of dyspnea.
- DRUG
-
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
Sponsors & Collaborators
-
Masaryk University
collaborator OTHER -
University Hospital Hradec Kralove
lead OTHER
Principal Investigators
-
Vladimir Koblizek, PhD · head of department
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-27
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- Czechia
Study Locations
More Related Trials
-
Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
NCT04551781 ·Status: COMPLETED ·Phase: NA
-
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
NCT02172781 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers
NCT01181700 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
NCT01818024 ·Status: COMPLETED ·Phase: PHASE1
-
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
NCT05628740 ·Status: COMPLETED ·Phase: PHASE1
-
Study To Estimate The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
NCT00977015 ·Status: COMPLETED ·Phase: PHASE1
-
This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
NCT01272375 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.
NCT00862667 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women
NCT01989949 ·Status: COMPLETED ·Phase: PHASE1
-
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
NCT00274066 ·Status: COMPLETED ·Phase: PHASE3
-
A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers
NCT01364519 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers
NCT02482324 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
NCT00650091 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Pharmacokinetics of FBR-002 for the Treatment of Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome
NCT05279352 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)
NCT01855230 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPF
NCT04244825 ·Status: WITHDRAWN ·Phase: PHASE2
-
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
NCT02657473 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
NCT05986318 ·Status: RECRUITING ·Phase: PHASE2
-
TD-0903 for ALI Associated With COVID-19
NCT04402866 ·Status: COMPLETED ·Phase: PHASE2
-
Bronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Bronchiectasis
NCT06209047 ·Status: RECRUITING ·Phase: PHASE4
-
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
NCT00794586 ·Status: COMPLETED ·Phase: PHASE2
-
NAL ER IPF Respiratory Function and Safety Study
NCT07036029 ·Status: RECRUITING ·Phase: PHASE1
-
Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia
NCT05205668 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
NCT01854645 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Effects of Dexpramipexole in Participants With Eosinophilic COPD
NCT06533553 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2