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NCT01650545 · ClinicalTrials.gov registry record · Phase 1

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

A Phase 1 study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT01650545: Completed Phase 1 study, sponsored by University of Maryland, Baltimore.

NCT01650545 is a Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01650545, a Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS). The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary end points.

Primary Outcome

Treatment failure defined as: BOS progression (\> 20% decline lung function), re-transplant, or death

Interventions

  • DRUG Liposomal aerosol cyclosporine
  • OTHER standard immune suppression, oral

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2012-07
Est. Completion 2019-11
Phase Phase 1
University of Maryland, Baltimore

560 total trials

What the finished NCT01650545 record still lists

NCT01650545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which Liposomal aerosol cyclosporine is the first listed.

NCT01650545 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01650545 about?

NCT01650545 is a clinical study titled "Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients". This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS). The primary objective is to evaluate the efficacy of liposomal cyclosp...

What is the current status of trial NCT01650545?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-07. Estimated completion is 2019-11.

What interventions are being tested in trial NCT01650545?

The interventions under investigation include: Liposomal aerosol cyclosporine (DRUG), standard immune suppression, oral (OTHER).

Who is sponsoring clinical trial NCT01650545?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01650545's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01650545, the US trial registry maintained by the National Library of Medicine. NCT01650545 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.