CIS001 Extension Study of Cyclosporine Inhalation Solution

CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938236

Acronym

CIS002

Enrollment

Registered

2009-07-13

Start date

2009-12-31

Completion date

2011-12-31

Last updated

2012-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant

Keywords

lung transplant, lung transplant recipient, bronchiolitis obliterans syndrome, bronchiolitis obliterans, single lung transplant, double lung transplant, heart-lung transplant, Aerosol

Brief summary

This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.

Interventions

DRUGCyclosporine 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Enrollment in study CIS001 2. Written informed consent for CIS002 3. Use of an effective means of contraception by women of childbearing potential

Exclusion criteria

1. Any unresolved or irreversible CIS-related ongoing serious adverse event 2. Subjects who have developed newly emergent conditions, injuries, diagnoses, physical examination findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk of treatment complications 3. Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine 4. Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant 5. Women who are breastfeeding 6. Subjects unable to comply with all protocol requirements and follow-up procedures 7. Subjects who discontinued from CIS002 to participate in another clinical trial and have received any investigational treatment (other than CIS) within 14 days of titration visit 1/baseline.

Design outcomes

Primary

Measure	Time frame
To assess the long-term safety of CIS administration	5 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026