Clinical Trials for Obliterative Bronchiolitis

This article provides information about ongoing clinical trials investigating treatments for Obliterative Bronchiolitis, specifically Bronchiolitis Obliterans Syndrome (BOS) occurring after lung transplantation. Currently, there is 1 clinical trial examining the long-term safety and effectiveness of Liposomal Ciclosporin A as an inhaled treatment for patients who have received lung transplants and developed this condition. (Also known as: Bronchiolitis Obliterans Syndrome, BOS)

Clinical trial locations

• Austria
  • Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation
• Belgium
  • Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation
• Denmark
  • Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation
• France
  • Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation
• Germany
  • Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation
• Spain
  • Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation

Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation

This trial is investigating Liposomal Ciclosporin A (L-CsA) as a long-term treatment option for patients who have developed Bronchiolitis Obliterans Syndrome after receiving a lung transplant. The condition causes inflammation and scarring in the small airways of the lungs, leading to progressive breathing difficulties and declining lung function.

Main inclusion criteria:

• Patients who have completed all visits in previous studies called BOSTON-1 or BOSTON-2 and did not withdraw consent or stop taking the study medication early
• Must be taking a maintenance regimen of immunosuppressive medications, including tacrolimus, a second agent like mycophenolate mofetil or azathioprine, and a corticosteroid such as prednisone
• May also be taking azithromycin for prevention or treatment of the condition
• Must be able to understand the study requirements, provide written consent, and be able to inhale medication in aerosol form
• Women of childbearing potential must have a negative pregnancy test and agree to use reliable birth control throughout the study

Main exclusion criteria:

• Patients who have not had a single or double lung transplant
• Patients who do not have Bronchiolitis Obliterans Syndrome
• Patients who are not within the specified age range for the study
• Patients who do not meet the clinical trial group requirements

Study focus and goals: The trial aims to assess the long-term safety and effectiveness of inhaled Liposomal Ciclosporin A when added to standard care. Researchers will monitor lung function, specifically measuring forced expiratory volume and forced vital capacity, to track disease progression. The study will also evaluate whether patients need re-transplantation, monitor quality of life using standardized questionnaires, and record hospitalization days. Regular assessments will include checking for adverse events, vital signs, physical examinations, and renal function.

Investigational drug: The study is testing L-CsA (Liposomal Ciclosporin A), which is administered as a powder for nebulizer solution that patients inhale. This medication works by inhibiting calcineurin, which reduces T-cell activity and decreases inflammation and immune response in the airways. It is being used in combination with standard immunosuppressive treatments to determine if it provides additional benefits for managing this condition.

This is a follow-up study to the earlier BOSTON-1 and BOSTON-2 trials and is being conducted across multiple European countries, with an estimated completion date of March 31, 2025.

Summary

Currently, there is one active clinical trial focused on Obliterative Bronchiolitis, specifically targeting Bronchiolitis Obliterans Syndrome that develops after lung transplantation. This trial is notable for being conducted across six European countries: Austria, Belgium, Denmark, France, Germany, and Spain, indicating a coordinated international effort to study this condition.

The trial represents a continuation of previous research, as it is designed as a follow-up study for patients who participated in earlier BOSTON-1 and BOSTON-2 trials. The focus is on evaluating the long-term safety and effectiveness of an inhaled treatment rather than testing a completely new approach, which suggests that initial findings have been promising enough to warrant extended investigation.

The study emphasizes the importance of combination therapy, testing Liposomal Ciclosporin A alongside standard immunosuppressive treatments that lung transplant recipients typically require. This approach reflects the complex nature of managing transplant-related complications and the need for comprehensive treatment strategies.