CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 284 enrolled
Drug / intervention
Cyclosporine Inhalation Solution (CIS)drug
Likely dose
Cyclosporine Inhalation Solution (CIS) 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00755781
NCT00755781Phase 3Completed
CompareCT.gov

A Multi-Center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation

APT Pharmaceuticals, Inc.·interventional·Posted Sep 19, 2008·Updated Sep 17, 2012

In Brief

A Phase 3 clinical trial evaluating Cyclosporine Inhalation Solution (CIS) for Lung Transplant. Completed, enrolled 284 participants across 19 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Transplant
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.8 years ago

Interventions

Cyclosporine Inhalation Solution (CIS)drug

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)