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New inhaled antifungal shows promise for lung transplant patients

NCT ID NCT05037851

Disease control Sponsor: Pulmocide Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called opelconazole, given as a mist through a nebulizer, to prevent a serious fungal lung infection (aspergillosis) in people who had a lung transplant. The trial involved 102 participants and compared the drug to standard care. The main goal was to see how safe and tolerable the treatment was over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Opelconazole (nebulized antifungal drug)
What this could lead to
If successful, this could provide a safer, more effective way to prevent dangerous fungal infections in lung transplant patients.
What could go wrong
This is a small, early-phase trial focused on safety and tolerability, not yet proving the drug prevents infections. Results may not apply to all transplant patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Nov 2021

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 2\. Participant has received either a single or double lung transplant but did not receive any other organ transplant (e.g., heart, kidney, etc.) at the time of the lung transplantation. History of prior transplant (\>1 year) is acceptable 6a. (De novo prophylaxis immediately post transplant): participant must be ready to be randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive care unit (ICU) after the transplant surgery or 6b. (Pre-emptive therapy): participant must meet all of the following: * Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13 weeks) after a lung transplant. Colonization is defined according to the 2010 International Society for Heart Lung Transplantation (ISHLT) Consensus Statement definition criteria for colonization * Without evidence of pulmonary fungal disease * Must be ready to start anti-mold medication within 96 hours after the positive culture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported Key Exclusion Criteria: 1. Participant would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy 2. Fungal disease requiring systemic antifungal treatment at the time of transplant 3. Has received a mold active antifungal agent post-transplant (Note: a participant who receives a mold active antifungal agent within 24 hours before, during, or after the transplant procedure will not be excluded if the mold active medication was stopped within 72 hours of returning to the ICU after the transplant surgery, or prior to randomization (whichever happens first) 4. Has previously received opelconazole 5. Is receiving, or who is due to receive at any time during the study, an investigational medicinal agent 6. Is participating, or who is due to participate at any time during the study, in a therapeutic clinical trial. For any other trials (e.g. observational or using approved medication), consultation with Pulmocide and the medical monitor is required. 7. Has an endobronchial stent in situ 8. Known history of allergy, hypersensitivity, or any previous serious reaction to any component of the opelconazole formulation, azoles, echinocandins, or amphotericin B 9. Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) \> 5 x the upper limit of normal (ULN) 10. Any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the participant from participation in the study 12\. Life expectancy is not expected to be sustained for the duration of the trial (16 weeks), in the opinion of the investigator Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

pulmonary aspergilloma aspergillosis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary aspergillosis

Contacts and locations

Locations

  • Clinical Research Site

    Phoenix, Arizona, 85013, United States

  • Clinical Research Site

    La Jolla, California, 92037, United States

  • Clinical Research Site

    Los Angeles, California, 90095, United States

  • Clinical Research Site

    Jacksonville, Florida, 32224, United States

  • Clinical Research Site

    Tampa, Florida, 33606, United States

  • Clinical Research Site

    Maywood, Illinois, 60153, United States

  • Clinical Research Site

    New York, New York, 10016, United States

  • Clinical Research Site

    The Bronx, New York, 10467, United States

  • Clinical Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Research Site

    Philadelphia, Pennsylvania, 19140, United States

  • Clinical Research Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Clinical Research Site

    Nashville, Tennessee, 37232, United States

  • Clinical Research Site

    Dallas, Texas, 75246, United States

  • Clinical Research Site

    Edmonton, T6G 1Z1, Canada

  • Clinical Research Site

    Toronto, M5G 2N2, Canada

  • Clinical Research Site 1

    Houston, Texas, 77030, United States

  • Clinical Research Site 2

    Houston, Texas, 77030, United States

  • Clinical Research Site 3

    Houston, Texas, 77030, United States

  • Research Site

    St Louis, Missouri, 63110, United States

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