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Study on the Effects of Inhaled Furosemide and Oral Levodropropizine on Breathing Difficulty in Patients with Advanced Lung Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two treatments on dyspnea, which is a feeling of shortness of breath, in patients with advanced lung diseases. The diseases being studied include asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, lung cancer, and other conditions that affect the lungs, such as those caused by COVID-19 or certain medications. The treatments being tested are Furosemide, which will be inhaled, and Levodropropizine, which will be taken orally as drops.

The purpose of the study is to validate the safety and tolerability of inhaled Furosemide in patients experiencing dyspnea. Participants will receive a single dose of inhaled Furosemide and will be monitored for any side effects. The study will also evaluate how well the treatments help reduce the sensation of breathlessness by using scales that measure the severity of dyspnea. These scales include the visual-analog scale (VAS) and the Borg scale, which are tools used to assess how patients perceive their breathing difficulties.

Throughout the study, participants will be asked to report any changes in their symptoms and any side effects they experience. The study aims to determine if the treatments can achieve a meaningful improvement in the participants' breathing comfort. The trial is expected to run until early 2026, with recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), understanding of the study, and ability to assess breathing difficulty using specific scales.

    Consent is required, and for women of childbearing age, agreement to abstain from sexual intercourse during the study is necessary.

  2. Step 2

    Initial assessment

    An initial assessment of breathing difficulty is conducted using the visual-analog scale (VAS) and the Borg scale. A score of 50 or more on the VAS or 5 or more on the Borg scale is required.

  3. Step 3

    Medication administration

    The study involves the administration of two medications: inhaled furosemide and perorally administered levodropropizine.

    Furosemide is administered through inhalation, while levodropropizine is taken orally.

  4. Step 4

    Monitoring and evaluation

    The primary focus is on the safety and tolerability of a single dose of inhaled furosemide, monitored through any treatment-related adverse events.

    The effect on breathing difficulty is evaluated by changes in the VAS and Borg scale scores. A clinically relevant change is defined as a 1-point change on the Borg scale or a 10 mm change on the VAS.

  5. Step 5

    Completion of participation

    The study is expected to conclude by January 1, 2026. Participation involves regular assessments and monitoring until the end of the study period.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Must be able to **understand the study** and agree to participate by signing a consent form.
  • Must be able to **rate their breathing difficulty** using two specific scales: the visual-analog scale (VAS) and the Borg scale.
  • Must have a **lung disease** that causes breathing difficulty, such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, lung cancer, breathing issues after COVID-19, breathing problems caused by medication, or lung infection. The breathing difficulty should be rated by the patient as **50 points or more on the VAS** or **5 points or more on the Borg scale**.
  • If a woman is of childbearing age, she must agree to **avoid sexual intercourse** during the study period, which includes the time spent in the hospital. Childbearing age starts with the first menstrual period and ends 12 months after the last menstrual period, known as menopause.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing **dyspnea**, which means difficulty in breathing, cannot participate.
  • Patients who do not have advanced **lung disease** are excluded.
  • Individuals who are not within the specified age range for the study cannot join. The study is open to certain age groups only.
  • Both **male** and **female** patients are eligible, but those who do not identify as either may not be included.
  • Patients who are considered part of a **vulnerable population**, meaning they might need special protection or care, are not allowed to participate.
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Investigated drugs

  • Furosemide

    is a medication used in this trial in an inhaled form. It is typically used to reduce fluid buildup in the body, which can help relieve symptoms of shortness of breath in patients with advanced respiratory diseases. In this study, the focus is on assessing the safety and tolerability of inhaling this medication.

  • Levodropropizine

    is administered orally in this trial. It is commonly used to relieve cough and is being studied for its potential effects on reducing dyspnea, or difficulty breathing, in patients with advanced respiratory conditions. The trial aims to understand how this medication can help improve breathing comfort.

What is already known about the treatment

  • Furosemide

    This medication is administered through inhalation and is currently being studied for its safety and tolerability in patients experiencing difficulty breathing due to advanced lung disease. It is primarily used to manage symptoms of dyspnea, or shortness of breath. Furosemide works by reducing fluid buildup in the lungs, which can help ease breathing. It is classified as a diuretic, commonly used to remove excess fluid from the body.

  • Levodropropizine

    This medication is taken orally and is being evaluated for its effects on reducing the perception of breathlessness in patients with severe respiratory conditions. It is mainly indicated for the relief of cough and related symptoms. Levodropropizine acts by suppressing the cough reflex, providing relief from persistent coughing. It belongs to the class of medications known as cough suppressants.

Investigated diseases

Dyspnea – Dyspnea, commonly known as shortness of breath, is a condition where individuals experience difficulty in breathing or a sensation of not getting enough air. It can occur suddenly or develop gradually and is often associated with lung diseases, heart conditions, or anxiety. In advanced lung disease, dyspnea can become more frequent and severe, impacting daily activities and quality of life. The sensation of breathlessness may vary in intensity and can be triggered by physical exertion, environmental factors, or even at rest. Patients may describe it as a tightness in the chest, a feeling of suffocation, or an inability to take a deep breath. Managing dyspnea involves understanding its triggers and implementing strategies to alleviate the discomfort.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514672-41-00Protocol codeINFURO_2023Estimated enrolment114 patientsSponsorFakultni Nemocnice Hradec Kralove

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).