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

NCT04039347 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Bronchiolitis Obliterans
  • Obliterative Bronchiolitis
  • Bronchiolitis Obliterans Syndrome

Interventions

DRUG

Liposomal Cyclosporine A 5 mg

delivered via the PARI eFlow® device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm

DRUG

Liposomal Cyclosporine A 10 mg

delivered via the PARI eFlow® device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm

Sponsors & Collaborators

  • Zambon SpA

    lead INDUSTRY

Principal Investigators

  • Paola R Castellani, MD · Zambon SpA, Chief Medical Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2026-02-25
Completion
2026-02-25
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Israel
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039347 on ClinicalTrials.gov