Ongoing Clinical Trials for Bronchopulmonary Aspergillosis
Currently, there are 4 clinical trials investigating new treatments and diagnostic methods for bronchopulmonary aspergillosis. These studies are taking place across Europe, primarily in Spain, Germany, France, Netherlands, Belgium, Austria, Italy, Greece, and Hungary. The trials focus on evaluating new antifungal medications including rezafungin, opelconazole, and combination therapies, as well as innovative imaging techniques to better diagnose this fungal lung infection.
Clinical trial locations
- Austria
- Belgium
- France
- Effectiveness and Safety of Rezafungin in Adults with Chronic Pulmonary Aspergillosis Who Have Limited Treatment Options
- Study on the Safety and Effectiveness of Opelconazole with Other Antifungal Treatments for Patients with Hard-to-Treat Lung Aspergillosis
- Study Comparing Itraconazole and Nebulised Amphotericin B with Itraconazole Alone for Patients with Chronic Pulmonary Aspergillosis
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Spain
Effectiveness and Safety of Rezafungin in Adults with Chronic Pulmonary Aspergillosis Who Have Limited Treatment Options
This study is evaluating rezafungin as a treatment option for adults with chronic pulmonary aspergillosis who cannot receive standard azole antifungal therapy. The trial focuses on patients whose condition is progressing or who have significant symptoms from the fungal lung infection.
Who can participate: Adults aged 18 or older who have been diagnosed with chronic pulmonary aspergillosis for at least 3 months and are unable to receive standard azole therapy. Participants must either show worsening on lung scans or have severe symptoms requiring antifungal treatment. Women of childbearing potential must use two highly effective birth control methods throughout the study and for 30 days afterward. Men must use barrier contraception or practice abstinence during the study and for 120 days after the last dose.
Who cannot participate: People with a history of severe allergic reactions to similar medications, pregnant or breastfeeding women, those with certain liver or kidney problems, individuals with active cancer not in remission, people who have had organ transplants, those with HIV/AIDS, individuals with certain heart conditions, and those taking medications that might interact with the study drug.
Study focus: The main goal is to determine if six months of rezafungin treatment can improve the condition of patients with limited treatment alternatives. During the study, participants will be monitored through respiratory symptom assessments, weight measurements, CT scans, and blood tests to measure Aspergillus antibody levels. Quality of life questionnaires will also be completed. The study will track response to medication by measuring changes in antibody levels, need for additional medications, hospitalizations, and any side effects.
Investigational drug: Rezafungin acetate is an echinocandin antifungal medication given as an intravenous infusion at a dose of 200 mg. It works by disrupting the formation of the fungal cell wall, preventing the fungus from growing. This medication is still in Phase 2 clinical trials.
Study on Imaging Lung Aspergillosis Using Gallium-68 Deferoxamine for Patients with Pulmonary Aspergillosis
This trial is exploring a new imaging method to better visualize fungal lung infections using a special compound called 68Ga-DFO in PET/CT scans. The purpose is to see if this technique can effectively show the presence and location of the infection in the lungs.
Who can participate: Adults aged 18 or older who have suspected chronic pulmonary aspergillosis or allergic bronchopulmonary aspergillosis. Participation should not significantly interfere with regular medical care and follow-up appointments.
Who cannot participate: Patients outside the specified age range, those from vulnerable populations needing special protection, patients without a confirmed diagnosis, those unable to undergo PET/CT scans, patients with medical conditions that might interfere with the study, pregnant or breastfeeding women, and those currently participating in another clinical trial.
Study focus: The research aims to determine if the 68Ga-DFO compound can effectively highlight fungal infections in lung imaging. Participants will receive the compound through an intravenous injection, followed by a PET/CT scan. Researchers will analyze how the compound is taken up in different parts of the lungs and compare it to factors like iron levels and the presence of other infections. This could lead to better diagnostic methods for this condition.
Investigational agent: 68Ga-DFO-B is a diagnostic imaging agent that binds to the Aspergillus fungus, making it visible on PET/CT scans. It combines gallium-68 with deferoxamine mesilate to target areas of infection, allowing for clear imaging results.
Study on the Safety and Effectiveness of Opelconazole with Other Antifungal Treatments for Patients with Hard-to-Treat Lung Aspergillosis
This study is testing whether adding PC945 (opelconazole), delivered as an inhaled mist through a nebulizer, to existing antifungal therapy can improve outcomes for patients with refractory invasive pulmonary aspergillosis, a serious lung infection that doesn’t respond to standard treatments.
Who can participate: Adults with proven or probable refractory invasive pulmonary aspergillosis that has not responded to adequate antifungal therapy. Participants of all genders are eligible, including those who may be part of vulnerable populations.
Who cannot participate: Patients without refractory invasive pulmonary aspergillosis, those outside the specified age range, patients unable to follow study procedures or requirements, those with other medical conditions that might interfere with the study, pregnant or breastfeeding women, those participating in another clinical trial, and patients with a history of allergic reactions to the study medication.
Study focus: The trial compares PC945 combined with other antifungal medications against a placebo plus standard therapy over a 12-week period. The goal is to determine if adding inhaled opelconazole can achieve better overall response in managing this challenging lung infection. Participants will be monitored throughout the study to assess both effectiveness and safety.
Investigational drugs: PC945 (opelconazole) is an inhaled antifungal medication given through a nebulizer. It targets and inhibits the growth of the Aspergillus fungus directly in the lungs. The medication is used alongside systemic antifungal therapy, which refers to standard treatments that work throughout the body to eliminate fungal infections.
Study Comparing Itraconazole and Nebulised Amphotericin B with Itraconazole Alone for Patients with Chronic Pulmonary Aspergillosis
This trial compares two treatment approaches over six months: a combination of oral itraconazole with inhaled AmBisome versus itraconazole alone. The study aims to determine which approach is more effective in improving the health of patients with chronic pulmonary aspergillosis.
Who can participate: Men and women aged 18 or older with confirmed Aspergillus bronchopulmonary infection that can be cavitary, fibrotic, necrotizing, or nodular, verified by chest CT scan. Participants must meet at least one of these criteria: positive anti-Aspergillus antibodies, positive detection of Aspergillus in lung samples, or presence of fungal filaments in tissue samples. Women of childbearing age must have a negative pregnancy test, use highly effective contraception, and continue it for at least the first 12 months of the study. Patients must be affiliated with the national health care system and provide informed consent.
Who cannot participate: Patients with a single aspergilloma (a single clump of fungus in the lungs), those who are severely immunocompromised (having a significantly weakened immune system), and patients who are part of vulnerable populations at higher risk of harm or exploitation.
Study focus: The trial evaluates both clinical and radiological improvements over six months of treatment. After the treatment period, there is a 24-month follow-up to observe long-term effects or relapses. The study assesses quality of life using questionnaires and tracks major health events and hospital visits related to respiratory symptoms. This single-blind study means patients don’t know which treatment group they’re in, helping ensure unbiased results.
Investigational drugs: Itraconazole is an oral antifungal medication taken in 100 mg capsules that works by stopping fungal growth. It inhibits ergosterol synthesis, a vital component of fungal cell membranes. AmBisome is a nebulized form of amphotericin B inhaled directly into the lungs. It works by binding to ergosterol in the fungal cell membrane, creating pores that lead to fungal cell death. The study tests whether using both medications together is more effective than itraconazole alone.
Summary
These four clinical trials represent current research efforts to improve treatment options for patients with various forms of pulmonary aspergillosis. The studies are concentrated in Western European countries, particularly Spain, Germany, France, and Austria, with multiple trials taking place across Belgium, Italy, and the Netherlands.
The research focuses on three main areas: testing new antifungal medications (rezafungin and opelconazole), exploring combination therapies (itraconazole with inhaled amphotericin B), and developing better diagnostic imaging methods using gallium-68 deferoxamine. Notably, two trials specifically target patients with limited treatment options or refractory infections that don’t respond to standard therapies, addressing an important unmet medical need.
The trials employ different delivery methods including intravenous infusions, inhaled nebulized medications, and oral treatments, each designed to target the fungal infection effectively. Most studies run for 6-12 weeks of active treatment, with some including extended follow-up periods of up to 24 months to monitor long-term outcomes. All trials emphasize safety monitoring alongside effectiveness assessment, recognizing the serious nature of these fungal lung infections.
