Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
|ClinicalTrials.gov Identifier: NCT01439958|
Recruitment Status : Terminated (Core study 12011.201 was terminated.)
First Posted : September 23, 2011
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans||Drug: Inhalation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2012|
|Primary Completion Date :||July 2013|
|Study Completion Date :||December 2014|
Twice daily inhalation of L-CsA
Twice daily inhalation for a maximum of three years.
Other Name: aerosolized liposomal CsA
- Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) [ Time Frame: 3 years ]Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.
- 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 ]
Efficacy will be assessed mainly for the following efficacy endpoints:
- BOS-free survival
- Incidence of BOS
- Pulmonary function
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439958
|PARI Pharma GmbH|
|Graefelfing, Germany, 82166|
|Principal Investigator:||Claus Neurohr, MD||Ludwig-Maximilians - University of Munich|