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

NCT01439958 | Terminated Phase 3

• 2 other identifiers: 12011.2032011-004304-38
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis Obliterans

Keywords

Inhalation; Lung Transplantation; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201

  3 years

Study Arms (1)

L-CsA

EXPERIMENTAL

Twice daily inhalation of L-CsA

Drug: Inhalation

Interventions

Inhalation DRUG

Twice daily inhalation for a maximum of three years.

Also known as: aerosolized liposomal CsA

L-CsA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has completed the L-CsA clinical trial 12011.201
• 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
• 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
• Estimated life expectancy \> 6 months
• Capable of self-administration of medications
• Patient has stable creatinine levels

You may not qualify if:

• Patients with ongoing irreversible L-CsA related serious adverse events
• Patients with known hypersensitivity for ciclosporin A
• Patient receives mechanical ventilation
• Patients underwent pulmonary re-transplantation
• Patient is a pregnant or breast-feeding woman
• Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
• Patient receives any systemic or topical Rosuvastatin
• Patient has been previously enrolled in this study
• Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
• Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
• Patient is not eligible to continue IMP inhalation according to the Investigator's discretion

Sponsors & Collaborators

• Pari Pharma GmbH: lead

Study Sites (1)

PARI Pharma GmbH

Gräfelfing, 82166, Germany

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans; Respiratory Aspiration

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Claus Neurohr, MD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 23, 2011
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

DE (1)