A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients

• Conditions: Bronchiolitis Obliterans Syndrome; MedDRA version: 9.1Level: LLTClassification code 10049202Term: Bronchiolitis obliterans

• Registration Number: EUCTR2008-003801-15-GB
• Lead Sponsor: PARIPharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-24
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Subject’s written informed consent obtained prior to any screening procedure. For subjects below 18 years of age, the written informed consent is obtained from the subject’s legal representative
2.Received an allogeneic haematopoietic stem cell transplantation (HSCT)
3.Has a baseline FEV1 value available prior to HSCT according to Appendix III
4.Has a diagnosis of bronchiolitis obliterans (BOS) of grade 1, 2 or 3 and confirmation to initiate BOS-specific treatment based on declining FEV1 values according to Appendix III within 1 week prior to first IMP administration
5.Male or female, >/= 12 years of age
6.Capable of self-administration medications
7.Capable of understanding the purpose and risk of the clinical trial
8.Received at least 1 week prior to first IMP administration the following immunosuppressive agents and dosages for the treatment of chronic graft-versus-hostdisease (GVHD) including BOS:
a)Tacrolimus approximately 0.1 to 0.2 mg/kg/day adjusted to a target trough serum level (C0) of 5 to 15 µg/L
b)Prednisone 1 to 3 mg/kg/day for 2 to 6 weeks, tapered down subsequently
9.Female patients with reproductive potential must have a negative serum pregnancy test within 3 days prior to screening. 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 of the protocol
10.Estimated life expectancy > 6 months

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Received systemic or topical ciclosporin A within one week prior to IMP administration and during the clinical trial
2.Any active invasive bacterial, viral or fungal infection within one week prior to first IMP admiistration
3.Received systemic immunosuppressive therapy for chronic GVHD other than listed in the inclusion criteria within one week prior to first IMP administration
4.Has steroid-refractory or steroid-intolerant chronic GVHD due to insulin-dependent diabetes or symptomatic avascular necrosis
5.Current mechanical ventilation
6.Pregnant or breast-feeding woman
7.Has a known hypersensitivity to ciclosporin A
8.Has a serum creatinine value of more than 265 µmol/L (3 mg/dL) or chronic dialysis (haemodialysis)
9.Unlikely to comply with the visits, inhalation procedures or spirometric measurements scheduled in the protocol
10.Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
11.Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the subject’s participation in the clinical trial
12.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
13.Subject was previously included in the present clinical trial

Study & Design

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