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

Bronchiolitis Obliterans Clinical Trial

Official title:

A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01439958
• Other study ID #: 12011.203
• Secondary ID: 2011-004304-38
• Status: Terminated
• Phase: Phase 3
• First received: September 22, 2011
• Last updated: April 13, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Pari Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsAustria: Agency for Health and Food SafetyCanada: Health CanadaDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion Criteria:

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

2. Patients with known hypersensitivity for ciclosporin A

3. Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans

Intervention

Drug:
• Inhalation
Twice daily inhalation for a maximum of three years.

Locations

Country	Name	City	State
Germany	PARI Pharma GmbH	Graefelfing

Sponsors (1)

Lead Sponsor	Collaborator
Pari Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)	Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.	3 years	Yes
Secondary	Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201	Efficacy will be assessed mainly for the following efficacy endpoints: BOS-free survival; Incidence of BOS; Pulmonary function	3 years	No