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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 24 June 2013
Main ID:  EUCTR2008-003800-73-AT
Date of registration: 11/05/2009
Prospective Registration: Yes
Primary sponsor: PARI Pharma GmbH
Public title: 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
Scientific title: A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 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
Date of first enrolment: 08/07/2009
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003800-73
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
Phase: 
Countries of recruitment
Austria Belgium Canada Denmark Germany Spain United Kingdom
Contacts
Name: Director, Regulatory Affairs Pharma   
Address:  Lochhamer Schlag 21 82166 Graefelfing Germany
Telephone: 498974284647
Email: o.denk@pari.de
Affiliation:  PARi Pharma GmbH
Name: Director, Regulatory Affairs Pharma   
Address:  Lochhamer Schlag 21 82166 Graefelfing Germany
Telephone: 498974284647
Email: o.denk@pari.de
Affiliation:  PARi Pharma GmbH
Key inclusion & exclusion criteria
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 32 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000004855
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Intervention(s)

Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: 081400
Other descriptive name: Ciclosporine, Ciclosporina
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use

Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: 081400
Other descriptive name: Ciclosporine, Ciclosporina
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use

Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: Sodium Chloride
Other descriptive name: Sodium Chloride
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.25-

Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: Sodium Chloride
Other descriptive name: Sodium Chloride
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.25-

Primary Outcome(s)
Main Objective: The objective of this study is to assess the efficacy and safety of the addition of aerosolised L-CsA plus Standard of Care systemic immunosuppression as compared to aerosolised placebo plus Standard of Care therapy for prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant recipients.
Primary end point(s): • Cumulative BOS-free survival during the clinical trial period
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: 24 months
Secondary Outcome(s)
Secondary end point(s): Efficacy:
•Pulmonary function
oForced expiratory volume in one second (FEV1)
oForced mid-expiratory flow (FEF25-75)
oVital capacity (VC)
oTotal lung capacity (TLC)
at baseline, 12, 18 and 24 months after first IMP administration
•Incidence of BOS at 12, 18 and 24 months after first IMP administration
•Grading of BOS at 12, 18 and 24 months after first IMP administration
•Incidence of acute rejection grade A2 or higher at 12, 18 and 24 months after first IMP administration
•Walking distance from 6-minute walk test at 6, 12, and 24 months after first IMP administration
•Level of inflammatory markers, L-CsA and sucrose from bronchoalveolar lavage (BAL) from at least two visits during the clinical trial period
•Incidence of lung graft loss until 12, 18 and 24 months after first IMP administration
•Overall survival during the clinical trial period
Safety:
•Treatment-emergent adverse events (AEs)
•Incidence of invasive bacterial, viral or fungal infections 12, 18 and 24 months after first IMP administration
•Number of non-protocol procedures requiring overnight hospitalisations at 12, 18 and 24 months after first IMP administration
•Clinical laboratory
•Vital signs
•Physical examination
•L-CsA and tacrolimus whole blood trough levels at each visit
•Full L-CsA PK at Visit 1 and two additional days between Visits 2 and 16 for 80 randomised patients
Timepoint(s) of evaluation of this end point: 6,12,18 and 24 months
Secondary ID(s)
12011-201
2008-003800-73-DE
ISRCTN66069132
Source(s) of Monetary Support
PARI Pharma GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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