Disorder Related to Lung TransplantationPhase 1/2NCT01650545
Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
A Phase 1/2 study testing Liposomal aerosol cyclosporine and standard immune suppression, oral in people with Disorder Related to Lung Transplantation and Bronchiolitis Obliterans, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity
- What is being tested?
- Liposomal aerosol cyclosporine and standard immune suppression, oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Nov 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic rejection
- Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed
- Recipient of a double or single lung transplant
- Receiving immunosuppressive treatment according to institutional standards
Who cannot join
- Active invasive bacterial, viral or fungal infection
- Current mechanical ventilation
- Pregnant or breast-feeding woman
- Known hypersensitivity to cyclosporine A
- Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
- Receipt of an investigational drug as part of a clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation
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.
Read the detailed description
This is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) in the treatment of chronic rejection in lung transplant recipients with Grade 1 or 2 BOS.
The primary endpoints will include:
- Improvement or stabilization of pulmonary function test (FEV1) from baseline
- Stabilization of histology (no deterioration from baseline)
- Safety of the preparation
The secondary endpoints will include:
- Pharmacokinetics and distribution of CsA in blood -
- Change in cytokine levels from BAL specimens.
- Conditions
- Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity, Chronic Rejection of Lung Transplant
- Being tested
- Liposomal aerosol cyclosporine, standard immune suppression, oral
- Keywords
- case-control study, aerosolized liposomal cyclosporine A, bronchiolitis obliterans syndrome, Lung Transplantation, Lung function
- Medical subject headings
- Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal aerosol cyclosporineDrug
Also called cyclosporine
inhaled form of immune suppression
standard immune suppression, oralOther
Also called tacrolimus, rapamycin, sirolimus
conventional drug
Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Aerosol Cyclosporine | Experimental | Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant ) Receives: Drug: Liposomal aerosol cyclosporine; Other: standard immune suppression, oral |
| Conventional oral immune suppression | Active comparator | Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone.
Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well. Receives: Other: standard immune suppression, oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death
Measured: approximately 1 year
Secondary outcomes (2)
Cytokine Analysis From BAL Fluid in Lung
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
Measured: baseline to approximately 1 year
Overall Survival at 5 Years Follow-up
Number of participants surviving at 5 year follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2015
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldo T Iacono, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650545
- Sponsor's protocol ID
- HP-00049596
- Status last verified
- Mar 2018
- First submitted
- 27 Jun 2012
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50. doi: 10.1056/NEJMoa043204.
PubMed 16407509
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation
- ClinicalTrials.gov ID
- NCT01650545
- Acronym / sponsor ID
- HP-00049596
- Conditions
- Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity, Chronic Rejection of Lung Transplant
- Keywords
- case-control study, aerosolized liposomal cyclosporine A, bronchiolitis obliterans syndrome, Lung Transplantation, Lung function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Posted 25 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) in the treatment of chronic rejection in lung transplant recipients with Grade 1 or 2 BOS.
The primary endpoints will include:
- Improvement or stabilization of pulmonary function test (FEV1) from baseline
- Stabilization of histology (no deterioration from baseline)
- Safety of the preparation
The secondary endpoints will include:
- Pharmacokinetics and distribution of CsA in blood -
- Change in cytokine levels from BAL specimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Aerosol Cyclosporine | Experimental | Drug: Liposomal aerosol cyclosporine, Other: standard immune suppression, oralArm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant ) |
| Conventional oral immune suppression | Active comparator | Other: standard immune suppression, oralArm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone. Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic rejection
- Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed
- Recipient of a double or single lung transplant
- Receiving immunosuppressive treatment according to institutional standards
Key exclusion criteria (6 listed)
- Active invasive bacterial, viral or fungal infection
- Current mechanical ventilation
- Pregnant or breast-feeding woman
- Known hypersensitivity to cyclosporine A
- Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal aerosol cyclosporineAlso: cyclosporineinhaled form of immune suppression | Drug | Liposomal Aerosol Cyclosporine |
| standard immune suppression, oralAlso: tacrolimus, rapamycin, sirolimusconventional drug Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin | Other | Conventional oral immune suppression, Liposomal Aerosol Cyclosporine |
Primary outcome
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
Time frame: approximately 1 year
Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death
2 secondary outcomes
Cytokine Analysis From BAL Fluid in Lung
Time frame: baseline to approximately 1 year
Overall Survival at 5 Years Follow-up
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16407509Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50. doi: 10.1056/NEJMoa043204.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo T Iacono, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Liposomal aerosol cyclosporine and standard immune suppression, oral in people with Disorder Related to Lung Transplantation and Bronchiolitis Obliterans, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point (time frame: approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.