A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients

• Conditions: Prevention of bronchiolitis obliterans syndrome in lung transplant; MedDRA version: 14.0Level: LLTClassification code 10049202Term: Bronchiolitis obliteransSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2008-003800-73-DE
• Lead Sponsor: PARI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-29
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Patient’s written informed consent obtained prior to any screening procedure
2.Received a single lung, bilateral lung or heart/lung
transplantation between 6 weeks and 26 weeks prior to first IMP
administration
3.Male or female, >/= 18 years of age
4.Capable of self-administration of medications
5.Capable of understanding the purpose and risk of the clinical trial
6.Received within one week prior to first IMP administration the following immunosuppressive agents and dosages for maintenance therapy:
a) Tacrolimus and
b) Mycophenolate mofetil (MMF) 1 to 3 g/day and
c) Prednisone or any other steroid therapy; tapered down within the first 3 months after transplantation
7. Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
Both women and men must agree to use a medically acceptable method of contraception throughout the IMP treatment period and for 3 months after IMP discontinuation. Acceptable methods of contraception are disclosed in Appendix II
8.Estimated life expectancy > 6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

1.Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher
2.Any active invasive bacterial, viral or fungal infection within one week prior to first IMP administration
3.Received systemic maintenance immunosuppressive therapy other than listed in the inclusion criteria within one week prior to first IMP administration
4.Received any systemic or topical ciclosporin A within one week prior to first IMP administration and /or during the clinical trial
5 Received any systemic or topical Rosuvastatin within one week prior to first IMP administration and /or during the clinical trial
6.Current mechanical ventilation
7.Received a lung re-transplantation
8.Pregnant or breast feeding woman
9.Has known hypersensitivity to ciclosporin A
10.Has a serum creatinine value of more than 265 µmol/L (3 mg/dL) or chronic dialysis (haemodialysis)
11.Unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
12.Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
13.Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the patient’s participation in the clinical trial
14.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
15.Patient was previously enrolled in the present clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified