NCT01439958

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Pari Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Inhalation	Twice daily inhalation for a maximum of three years.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-07-01
• Completion: 2014-12-01
• First posted: 2011-09-23
• Last updated: 2015-04-14

Locations

1 site across 1 country: Germany