Clinical trial NCT01439958: Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bronchiolitis Obliterans
Keywords: Inhalation
Lung Transplantation
Cyclosporine
Lead sponsor: Pari Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
timeFrame: 3 years
Secondary outcomes:
measure: Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201
timeFrame: 3 years
Other outcomes:
Locations:
city: Graefelfing
country: Germany
facility: PARI Pharma GmbH
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Claus Neurohr, MD
role: PRINCIPAL_INVESTIGATOR
References: