CIS001 Extension Study of Cyclosporine Inhalation Solution (CIS002)

APT Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Lung Transplant

Treatments: Drug: Cyclosporine Inhalation Solution (CIS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938236

CIS002

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Inhaled cyclosporine

Other group

Description:

Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001

Treatment:

Drug: Cyclosporine Inhalation Solution (CIS)