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Completed

NCT Number: NCT00755781

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

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.

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Key information

Conditions

Lung Transplant Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Toronto, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cyclosporine Inhalation Solution (CIS)

Drug

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 names: Cyclosporine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

APT Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: CIS001

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 19, 2008
Registry last updated
Sep 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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