Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
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|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|
|Actual Primary Completion Date :||July 2013|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|