Evaluating inhaled furosemide and levodropropizine for treating breathlessness in lung disease patients
The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases
This study is testing if inhaled furosemide and levodropropizine can help people with lung disease who have trouble breathing feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Locations | 1 site (Hradec Králové) |
| Trial ID | NCT06252454 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and tolerability of inhaled furosemide in patients suffering from respiratory diseases and dyspnea. It employs a monocentric, double-blinded, crossover design where participants will receive either inhaled furosemide or a placebo, followed by an open-label administration of levodropropizine. The study will measure dyspnea severity and vital functions while monitoring for any adverse reactions. A total of 102 subjects will be randomized into two arms to evaluate the effectiveness of the treatments.
Who should consider this trial
Good fit: Ideal candidates include individuals with lung diseases such as asthma, COPD, or COVID-19 who experience significant dyspnea.
Not a fit: Patients with hypersensitivity to the study medications or severe liver or renal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients experiencing severe breathlessness due to lung diseases.
How similar studies have performed: While the approach of using inhaled furosemide is innovative, similar studies have shown promise in addressing dyspnea, making this a potentially valuable investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hradec Králové
- Plicní klinika, Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia (Recruiting)
Study contacts
- Principal investigator: Vladimir Koblizek, PhD — head of department
- Study coordinator: Michal Svarc, MD
- Email: michal.svarc@fnhk.cz
- Phone: +420 495 834 771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.