Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04039347

Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3) — BOSTON-3  

Bronchiolitis Obliterans Clinical Trial

Official title:
A Phase III, Extension Clinical Trial to Demonstrate Efficacy and Safety of Liposomal Cyclosprine A Via the PARI Investigational eFlow® Device and SoC in Treating Bronchiolitis Obliterans in Patients Post Single or Double Lung Transplant

Clinical Trial Summary

The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

Clinical Trial Description

This is a Phase III, multicenter, open-label, extension clinical trial of L-CsA for the treatment of BOS. Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to SoC, regardless of the randomization arm in prior trials. IMP will be administered by BID inhalation (morning/evening) using the L-CsA eFlow. Patients who did not receive L-CsA in BOSTON-1 or BOSTON-2 must remain in the clinic for at least 4 hours for observation after the first inhalation. At all subsequent visits, one dose administered via inhalation will be monitored by the clinical trial center personnel. In case patients receiving L-CsA undergo the last visit for BOSTON-1 or BOSTON-2 (Visit 9) on the same day as for Visit 1 for BOSTON-3, they will take the first dose for Boston 3 in the evening of this day. This first dose will not be supervised by the site staff. Nebulization time per inhalation dose is approximately 6-10 minutes for the 5 mg dose and 9-13 minutes for the 10 mg dose. Inhalations will be performed BID approximately 12 hours apart through a mouthpiece by slow and deep respiration using the L-CsA eFlow. A high efficiency particulate air filter is used to prevent environmental contamination during exhalation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04039347
Study type Interventional
Source Zambon SpA
Contact
Status Enrolling by invitation
Phase Phase 3
Start date March 12, 2020
Completion date September 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03603899 - Hp129 Xenon Imaging and BOS in Lung Transplantation Phase 1/Phase 2
Recruiting NCT04098445 - TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
Completed NCT02441413 - Transplant Optimization Using Functional Imaging (TROFI) N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Recruiting NCT00163696 - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease N/A
Completed NCT00029328 - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation Phase 1/Phase 2
Terminated NCT01163786 - A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD Phase 2
Recruiting NCT02627833 - Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO N/A
Completed NCT01211509 - Montelukast in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT01212406 - Vitamin D in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT00701922 - Surveillance Study of Viral Infections Following Lung Transplantation N/A
Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT05922761 - BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) Phase 2
Recruiting NCT05881538 - High Intensity Intervallic Training in Children With Bronchiolitis Obliterans N/A
Terminated NCT04655508 - Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation Phase 3
Withdrawn NCT02109237 - Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3 N/A
Completed NCT01327248 - Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans N/A
Recruiting NCT05932316 - Evaluating Bronchodilator Response in Patients With Bronchiectasis N/A
Active, not recruiting NCT03656926 - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2) Phase 3