A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients
- Conditions
- Prevention of bronchiolitis obliterans syndrome in lung transplantMedDRA version: 9.1Level: LLTClassification code 10049202Term: Bronchiolitis obliterans
- Registration Number
- EUCTR2008-003800-73-DK
- Lead Sponsor
- Pari Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 134
1. Subject’s written informed consent obtained prior to any screening procedure. 2.Received a single lung, bilateral lung or heart/lung transplantation within four weeks prior to first investigational medicinal product (IMP) administration
3.Male or female, >/= 18 years of age
4.Capable of self-administration 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 approximately 0.1 to 0.2 mg/kg/day adjusted to a target serum level (C0, trough) of 8 to 15 µg/L and
b) Mycophenolate mofetil (MMF) 1 to 3 g/day and
c) Prednisone orally; tapered down within the first 3 months after transplantation
7.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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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. Current mechanical ventilation
6. Received any systemic or topical Rosuvastatin within one week prior to the first IMP administration and/or during the clinical trial
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 the 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 subject’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. Subject was previously included in the present clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method