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Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation

NCT00755781 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2012-09-17

No results posted yet for this study

Summary

A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant recipients in addition to their standard immunosuppressive regimen.

Conditions

  • Lung Transplant

Interventions

DRUG

Cyclosporine Inhalation Solution (CIS)

Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration (up to 3 years)

Sponsors & Collaborators

  • APT Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Dilly, MD PhD · APT Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-09-30
Completion
2011-11-30

Countries

  • United States
  • Canada

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 NCT00755781 on ClinicalTrials.gov