Liposomal Cyclosporine A for Bronchiolitis Obliterans

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Bronchiolitis Obliterans+6 More
Liposomal Cyclosporine A - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding a certain drug to the standard care for double lung transplant recipients helps treat Bronchiolitis obliterans syndrome.

Eligible Conditions
  • Bronchiolitis Obliterans
  • Therapeutic immunosuppression
  • Chronic Lung Allograft Dysfunction (CLAD)
  • Lung
  • Lung Transplant; Complications
  • Lung Transplantation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Bronchiolitis Obliterans

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline through study completion (52 weeks)

Baseline through Week 48
Acute tolerability of L-CsA
Week 52
Adverse Events
Baseline to Week 48
Mean change in FEV1 (mL) from baseline to Week 48)
Mean change in FEV1/FVC from baseline to Week 48
Week 52
Hematology and Serum Chemistry Parameters
Week 52
Tiime to Progression of BOS

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Bronchiolitis Obliterans

Trial Design

3 Treatment Groups

Standard of Care alone
1 of 3
Standard of Care
1 of 3
L-CsA treatment plus SoC
1 of 3
Active Control
Experimental Treatment

152 Total Participants · 3 Treatment Groups

Primary Treatment: Liposomal Cyclosporine A · No Placebo Group · Phase 3

L-CsA treatment plus SoC
Drug
Experimental Group · 1 Intervention: Liposomal Cyclosporine A · Intervention Types: Drug
Standard of Care aloneNoIntervention Group · 1 Intervention: Standard of Care alone · Intervention Types:
Standard of Care
Drug
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through study completion (52 weeks)

Who is running the clinical trial?

Zambon SpALead Sponsor
28 Previous Clinical Trials
5,623 Total Patients Enrolled
3 Trials studying Bronchiolitis Obliterans
378 Patients Enrolled for Bronchiolitis Obliterans
Paola Castellani, MDStudy DirectorZambon SpA, Chief Medical Officer
2 Previous Clinical Trials
116 Total Patients Enrolled
2 Trials studying Bronchiolitis Obliterans
116 Patients Enrolled for Bronchiolitis Obliterans

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have been diagnosed with CLAD-BOS at least 12 months after lung transplantation.
You are taking a medication that suppresses the immune system
You are taking the same regimen for 4 weeks prior to randomization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.