Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)

NCT ID: NCT01439958

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.

Detailed Description

This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.

Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.

Conditions

Bronchiolitis Obliterans

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

L-CsA

Twice daily inhalation of L-CsA

Group Type: EXPERIMENTAL

Inhalation

Intervention Type: DRUG

Twice daily inhalation for a maximum of three years.

Interventions

Inhalation

Twice daily inhalation for a maximum of three years.

Intervention Type: DRUG

Other Intervention Names

aerosolized liposomal CsA

Eligibility Criteria

Inclusion Criteria

1. Patient has completed the L-CsA clinical trial 12011.201

2. Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study

3. Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study

4. Estimated life expectancy > 6 months

5. Capable of self-administration of medications

6. Patient has stable creatinine levels

4. Patient receives mechanical ventilation

5. Patients underwent pulmonary re-transplantation

6. Patient is a pregnant or breast-feeding woman

7. Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol

8. Patient receives any systemic or topical Rosuvastatin

9. Patient has been previously enrolled in this study

10. Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)

11. Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response

12. Patient is not eligible to continue IMP inhalation according to the Investigator's discretion

Exclusion Criteria

1. Patients with ongoing irreversible L-CsA related serious adverse events

2. Patients with known hypersensitivity for ciclosporin A

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pari Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Neurohr, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

PARI Pharma GmbH

Gräfelfing, , Germany

Countries

Germany

Other Identifiers

2011-004304-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12011.203

Identifier Type: -

Identifier Source: org_study_id