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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00755781
• Date of registration: 17/09/2008
• Prospective Registration: No
• Primary sponsor: APT Pharmaceuticals, Inc.
• Public title: Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation CIS001
• Scientific 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
• Date of first enrolment: September 2008
• Target sample size: 284
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00755781
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Stephen Dilly, MD PhD
• Affiliation: APT Pharmaceuticals, Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Transplant

Intervention(s)

Drug: Cyclosporine Inhalation Solution (CIS)

Primary Outcome(s)

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(s)

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]

All cause mortality [Time Frame: From study initiation through 2+ years after randomization]

Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization [Time Frame: From study initiation through 2+ years after randomization]

Secondary ID(s)

CIS001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors