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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: 23 February 2015
Main ID:  EUCTR2008-003800-73-DK
Date of registration: 18/08/2009
Prospective Registration: Yes
Primary sponsor: Pari Pharma GmbH
Public title: 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
Scientific title: 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
Date of first enrolment: 13/04/2010
Target sample size: 134
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: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Austria Belgium Denmark Germany Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
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

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. 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


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: 9.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
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: To establish a dosage with the most favourable risk/benefit ratio for the prevention of Bronchiolitis Obliterans Syndrome in lung transplant patients
Primary end point(s): Efficacy Endpoints:
• Mean forced expiratory volume in one second (FEV1) at baseline,12, 18 and 24
months after first IMP administration
• Mean FEV1 slope from baseline to 12, 18 and 24 months after first IMP administration
• Mean forced midexpiratory flow (FEF25-75), vital capacity (VC) and total lung capacity
(TLC) at baseline, 12, 18 and 24 months after first IMP administration
• Mean single breath diffusion capacity (DLCO) and capillary blood gases at 6, 12, 18
and 24 months after first IMP administration
• Cumulative mean incidence of BOS 12, 18 and 24 months after first IMP
administration
• Cumulative mean incidence of acute rejection grade A2 or higher 12, 18 and 24
months after first IMP administration
• Cumulative mean incidence of invasive bacteria, viral or fungal infection 12, 18 and
24 months after first IMP administration
• Cumulative mean incidence of lung graft lost 12, 18 and 24 after first IMP
administration
• Mean walking distance from 6 min walk test at baseline, 12, 18 and 24 months after first IMP administration
• Mean cumulative dose of maintenance immunosuppressant 12, 18 and 24 months after first IMP administration
• Mean cumulative number of overnight hospital stays 12, 18 and 24 months after first IMP administration
• Mean level of inflammatory markers and L-CsA from bronchoalveolar lavage (BAL)
from at least two visits during the clinical trial period
• Cumulative overall survival during the clinical trial period

Safety Endpoints:
• Incidence of AEs including clinically relevant laboratory findings until EoS
• Mean L-CsA blood levels at baseline and 6 month after first IMP administration
Secondary Objective: To compare efficacy and safety data from the IMP versus placebo and to evaluate IMP PK data in whole blood and BAL samples
Secondary Outcome(s)
Secondary ID(s)
12011.201
2008-003800-73-DE
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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