Trial · NCT01650545

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

NCT01650545, Phase 1, Phase 2, Completed, University of Maryland, Baltimore; results first posted 2017-10-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients. Trials, record NCT01650545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01650545

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
NCT number: NCT01650545
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 21 participants, actual
Lead sponsor: University of Maryland, Baltimore
Conditions: Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity, Chronic Rejection of Lung Transplant
Interventions: Liposomal aerosol cyclosporine, standard immune suppression, oral
First posted: 2012-07-26
Last updated: 2023-06-01
Results first posted: 2017-10-25

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number Of Participants With Chronic Rejection Who Met Primary Combined End-point	approximately 1 year	Treatment failure defined as: BOS progression (\> 20% decline lung function), re-transplant, or death
Secondary	Cytokine Analysis From BAL Fluid in Lung	baseline to approximately 1 year	Multiple cytokines were assessed as markers of lung inflammation that may be used in addition to biopsy data, collected per patient as clinically indicated during the follow-up interval. Values are reported as mean change from baseline in each group, per week
Secondary	Overall Survival at 5 Years Follow-up	5 years	Number of participants surviving at 5 year follow-up

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number Of Participants With Chronic Rejection Who Met Primary Combined End-point	approximately 1 year	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cytokine Analysis From BAL Fluid in Lung	baseline to approximately 1 year	pg/mL	MEAN
SECONDARY	Overall Survival at 5 Years Follow-up	5 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point	Liposomal Aerosol Cyclosporine		2		Participants
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point	Conventional Oral Immune Suppression		5		Participants
Cytokine Analysis From BAL Fluid in Lung	Liposomal Aerosol Cyclosporine	lL-1beta	-2	95% Confidence Interval -9.3 to 5.3	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Conventional Oral Immune Suppression	lL-1beta	3.3	95% Confidence Interval -4.3 to 10.9	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Liposomal Aerosol Cyclosporine	IL-2	-0.9	95% Confidence Interval -1.5 to 0.3	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Conventional Oral Immune Suppression	IL-2	-0.3	95% Confidence Interval -0.9 to 0.3	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Liposomal Aerosol Cyclosporine	IL-6	-2.0	95% Confidence Interval -7.9 to 3.9	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Conventional Oral Immune Suppression	IL-6	6.3	95% Confidence Interval 1.2 to 11.5	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Liposomal Aerosol Cyclosporine	IL-8	13.6	95% Confidence Interval -20.3 to 47.4	pg/mL
Cytokine Analysis From BAL Fluid in Lung	Conventional Oral Immune Suppression	IL-8	37.5	95% Confidence Interval 2.1 to 72.9	pg/mL

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Liposomal Aerosol Cyclosporine	11
Overall Study	STARTED	Conventional Oral Immune Suppression	10
Overall Study	COMPLETED	Liposomal Aerosol Cyclosporine	11
Overall Study	COMPLETED	Conventional Oral Immune Suppression	10
Overall Study	NOT COMPLETED	Liposomal Aerosol Cyclosporine	0
Overall Study	NOT COMPLETED	Conventional Oral Immune Suppression	0

Source ClinicalTrials.gov

Adverse events226

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Atrial flutter	Cardiac disorders	Liposomal Aerosol Cyclosporine	1	11
other	Atrial flutter	Cardiac disorders	Conventional Oral Immune Suppression	0	10
other	Carotid atherosclerosis	Cardiac disorders	Liposomal Aerosol Cyclosporine	1	11
other	Carotid atherosclerosis	Cardiac disorders	Conventional Oral Immune Suppression	0	10
other	Chest pain	Cardiac disorders	Liposomal Aerosol Cyclosporine	1	11
other	Chest pain	Cardiac disorders	Conventional Oral Immune Suppression	0	10
other	Congestive heart failure	Cardiac disorders	Liposomal Aerosol Cyclosporine	0	11
other	Congestive heart failure	Cardiac disorders	Conventional Oral Immune Suppression	1	10
other	Myocardial infarction	Cardiac disorders	Liposomal Aerosol Cyclosporine	0	11
other	Myocardial infarction	Cardiac disorders	Conventional Oral Immune Suppression	1	10

1 to 10 of 226Source ClinicalTrials.gov

See all 226 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Liposomal Aerosol Cyclosporine	6	11
Total, all-cause mortality	Conventional Oral Immune Suppression	10	10
Total, other adverse events	Liposomal Aerosol Cyclosporine	11	11
Total, other adverse events	Conventional Oral Immune Suppression	10	10
Total, serious adverse events	Liposomal Aerosol Cyclosporine	8	11
Total, serious adverse events	Conventional Oral Immune Suppression	8	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
16407509	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: Number Of Participants With Chronic Rejection Who Met Primary Combined End-point	Trial comparisons
Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: Overall Survival at 5 Years Follow-up	Trial comparisons
Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: deaths from any cause	Trial comparisons
Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01650545

GET https://conductscience.org/api/trials/v1/NCT01650545/events?page=2

API reference For AI assistants