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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650545
First Posted: July 26, 2012
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aldo Iacono, University of Maryland
Results First Submitted: October 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Disorder Related to Lung Transplantation
Bronchiolitis Obliterans
Decreased Immunologic Activity
Chronic Rejection of Lung Transplant
Interventions: Drug: Liposomal aerosol cyclosporine
Other: standard immune suppression, oral

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Liposomal Aerosol Cyclosporine

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 )

Liposomal aerosol cyclosporine: inhaled form of immune suppression

standard immune suppression, oral: conventional drug

Conventional Oral Immune Suppression

Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone

standard immune suppression, oral: conventional drug


Participant Flow:   Overall Study
    Liposomal Aerosol Cyclosporine   Conventional Oral Immune Suppression
STARTED   11   10 
COMPLETED   11   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Liposomal Aerosol Cyclosporine

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 )

Liposomal aerosol cyclosporine: inhaled form of immune suppression

standard immune suppression, oral: conventional drug

Conventional Oral Immune Suppression

Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone

standard immune suppression, oral: conventional drug

Total Total of all reporting groups

Baseline Measures
   Liposomal Aerosol Cyclosporine   Conventional Oral Immune Suppression   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   10   21 
Age 
[Units: Years]
Mean (Full Range)
 59.1 
 (35 to 81) 
 63.8 
 (32 to 75) 
 61.3 
 (32 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  45.5%      2  20.0%      7  33.3% 
Male      6  54.5%      8  80.0%      14  66.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  27.3%      2  20.0%      5  23.8% 
White      8  72.7%      8  80.0%      16  76.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   11   10   21 


  Outcome Measures
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1.  Primary:   The Number of Lung Allograft Recipients Randomized With Bronchiolitis Obliterans Whom Had Progression of Disease in the L-CsA Arm Versus the Standard of Care Arm Receiving Conventional Immune Suppression Exclusively.   [ Time Frame: 1 year post randomization ]

2.  Primary:   Number Of Participants With Chronic Rejection Who Expired   [ Time Frame: up to 5 years ]

3.  Secondary:   Cytokine Analysis From BAL Fluid in Lung   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aldo Tullio Iacono
Organization: University of Maryland
phone: 410 328 4351
e-mail: aiacono@umm.edu


Publications:

Responsible Party: Aldo Iacono, University of Maryland
ClinicalTrials.gov Identifier: NCT01650545     History of Changes
Other Study ID Numbers: HP-00049596
First Submitted: June 27, 2012
First Posted: July 26, 2012
Results First Submitted: October 24, 2017
Results First Posted: October 25, 2017
Last Update Posted: November 22, 2017