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Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation (CIS001)

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ClinicalTrials.gov Identifier: NCT00755781
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Transplant Drug: Cyclosporine Inhalation Solution (CIS) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CIS
CIS in addition to standard immunosuppressive regimen.
Drug: Cyclosporine Inhalation Solution (CIS)
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)
Other Name: Cyclosporine

No Intervention: SOC
Standard of care (SOC) therapy for lung transplant recipients



Primary Outcome Measures :
  1. Duration of BOS-free survival. Other causes for the decline should be excluded by bronchoscopy and other diagnostic testing performed at the discretion of the investigator. The diagnosis of BOS will be determined by the Outcomes Committee [ Time Frame: Assessed when symptoms of syndrome present ]

Secondary Outcome Measures :
  1. Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization [ Time Frame: From study initiation through 2+ years after randomization ]
  2. All cause mortality [ Time Frame: From study initiation through 2+ years after randomization ]
  3. Duration of event-free survival, corresponding to the length of time between date of randomization and either death or the occurrence of serious bacterial and viral infections that start in the lungs (defined by reporting of a SAE) [ Time Frame: From study initiation through 2+ year after randomzation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A recipient of a single or double lung transplant (including heart-lung transplant)
  • Age 18 years or older
  • Able to produce a forced expiratory volume in one second (FEV1) of greater than one liter at randomization
  • Eligible subjects must be enrolled within 70 days after receiving a lung transplant
  • Clinical status sufficiently stable to enable routine post-transplant bronchoscopy with bronchoalveolar lavage (BAL) and chest X-ray (or equivalent i.e., chest computerized tomogram (CT)) prior to screening

Exclusion Criteria:

  • Lung re-transplantation
  • Documented allergy to propylene glycol and/or cyclosporine
  • Documented respiratory or anastomotic infections unless on appropriate antimicrobial therapy with evidence of clinical response
  • Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
  • Women who are breastfeeding
  • Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
  • Malignancies diagnosed within one year prior to screening (with the exception of non-melanomatous skin cancers)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755781


Locations
Show Show 19 study locations
Sponsors and Collaborators
APT Pharmaceuticals, Inc.
Investigators
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Study Director: Stephen Dilly, MD PhD APT Pharmaceuticals, Inc.
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00755781    
Other Study ID Numbers: CIS001
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012
Keywords provided by APT Pharmaceuticals, Inc.:
lung transplant
lung transplant recipient
bronchiolitis obliterans syndrome
bronchiolitis obliterans
single lung transplant
double lung transplant
heart-lung transplant
Aerosol
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors