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

This study has been terminated.
(Core study 12011.201 was terminated.)
Sponsor:
Information provided by (Responsible Party):
Pari Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01439958
First received: September 22, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Bronchiolitis Obliterans
Drug: Inhalation
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pari Pharma GmbH:

Primary Outcome Measures:
  • Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.


Secondary Outcome Measures:
  • Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Efficacy will be assessed mainly for the following efficacy endpoints:

    • BOS-free survival
    • Incidence of BOS
    • Pulmonary function


Enrollment: 14
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-CsA
Twice daily inhalation of L-CsA
Drug: Inhalation
Twice daily inhalation for a maximum of three years.
Other Name: aerosolized liposomal CsA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439958

Locations
Germany
PARI Pharma GmbH
Graefelfing, Germany, 82166
Sponsors and Collaborators
Pari Pharma GmbH
Investigators
Principal Investigator: Claus Neurohr, MD Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Pari Pharma GmbH
ClinicalTrials.gov Identifier: NCT01439958     History of Changes
Other Study ID Numbers: 12011.203, 2011-004304-38
Study First Received: September 22, 2011
Last Updated: September 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Austria: Agency for Health and Food Safety
Canada: Health Canada
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pari Pharma GmbH:
Inhalation
Lung Transplantation
Cyclosporine

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 23, 2014