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Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

NCT00633373 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2012-09-17

No results posted yet for this study

Summary

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

Conditions

  • Lung Transplant

Interventions

DRUG

Cyclosporine Inhalation Solution

Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.

Sponsors & Collaborators

  • APT Pharmaceuticals, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

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 NCT00633373 on ClinicalTrials.gov