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

Arm | Intervention/treatment |
---|---|
Active Comparator: CIS
CIS in addition to standard immunosuppressive regimen.
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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
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- 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 ]
- Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization [ Time Frame: From study initiation through 2+ years after randomization ]
- All cause mortality [ Time Frame: From study initiation through 2+ years after randomization ]
- 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 |
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)

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

Study Director: | Stephen Dilly, MD PhD | APT Pharmaceuticals, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
lung transplant lung transplant recipient bronchiolitis obliterans syndrome bronchiolitis obliterans |
single lung transplant double lung transplant heart-lung transplant Aerosol |
Lung Diseases, Obstructive Lung Diseases Cyclosporine Cyclosporins Bronchiolitis Bronchiolitis Obliterans Respiratory Tract Diseases Bronchitis Respiratory Tract Infections Infections Bronchial Diseases |
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 |