The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Advanced Respiratory Diseases (INFURO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Hradec Kralove

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

27 Feb 2024 → ongoing

Decision date (initial)

2024-08-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fakultní nemocnice Hradec Králové

External identifiers

EU CT number

2024-514672-41-00

EudraCT number

2018-001298-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Validation of the safety and tolerability of inhaled furosemide in patients with dyspnea.

Secondary objectives 2

1. Verification of the effect of inhaled furosemide (FSM) on reducing shortness of breath in patients with advanced stages of respiratory diseases, especially in palliative care, in whom no other causal influence on shortness of breath is possible.
2. Determination of a possible additive effect after the subsequent administration of oral levodropropizine (LDP) on the suppression of dyspnea.

Conditions and MedDRA coding

dyspnea perception in patients with advanced lung disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years
2. Ability to understand the essence of the study and express consent to the study by signing the Informed Consent form
3. The patient's ability to assess dyspnea on the visual-analog scale (VAS) and on the Borg scale
4. The presence of lung disease (asthma, chronic obstructive pulmonary disease, interstitial lung disease, oncological disease with lung involvement, patients with dyspnea after COVID19, drug-induced dyspnea, lung infection) leading to acute or chronic dyspnea, which will currently be screened for the study assessed by the patient on the visual analog scale (VAS) with a value of 50 points and more and/or on the Borg scale with a value of 5 points and more
5. In the case of a woman of childbearing age, consent to abstain from sexual intercourse for the duration of participation in the study (i.e. for the duration of hospitalization). Note For evaluation purposes, menarche is considered to be the beginning of childbearing age, and the end is considered to be the end of the 12th month of amenorrhea from the last menstruation (menopause) at the usual age for the physiological cessation of ovarian function.

Exclusion criteria 15

1. Hypersensitivity to the medicinal substance or to any auxiliary substance of furosemide or levodropropizine
2. Disorder of mucociliary clearance (Kartagener's syndrome, ciliary dyskinesia)
3. Severe liver disorders in Child Pugh stage B – C cirrhosis
4. Renal insufficiency with clearance < 35 ml/min
5. Unstable patient requiring frequent changes or adjustments in medication and treatment
6. Patients on continuous i.v. medication or with the need to adjust therapy more than once every 4 hours
7. Ineligibility to participate in all study procedures
8. Pregnancy, breastfeeding
9. Participation in another clinical trial involving the administration of an investigational medicinal product within 28 days (or 5 half-lives, whichever is longer) prior to screening
10. The presence of COVID-19, if it is not possible to ensure that all study activities are carried out in isolation from other patients, including entries in the source and study documentation, meeting the currently valid hygiene regulations
11. Hypersensitivity to sulfonamides (e.g. to sulfonylurea derivatives or to sulfonamide antibiotics)
12. Severe hypokalemia
13. Severe hyponatremia
14. Hypovolemia and with or without hypotension
15. Dehydration

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety and tolerability of a single dose of inhaled furosemide assessed as the incidence and nature of all reported treatment-related adverse events.

Secondary endpoints 1

1. The effect of examined substances to suppress dyspnoea will be evaluated by changing to a visually analog scale (VAS) and the Borg scale. Changes on both steps will be evaluated statistically at the level of 5% probability and it will be determined whether the changes have achieved minimum clinically relevant changes against the default values. As a minimum clinically relevant change is considered 1 point in the Brog scale and 10 mm in VAS.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Hradec Kralove

Sponsor organisation

Fakultni Nemocnice Hradec Kralove

Address

Sokolska 581

City

Novy Hradec Kralove

Postcode

500 03

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Hradec Kralove

Contact name

Michal Švarc

Public contact point

Organisation

Fakultni Nemocnice Hradec Kralove

Contact name

Johana Krempová

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications