Bronchiolitis obliterans Respiratory Other chronic obstructive pulmonary disease
Conditions
Interventions
This trial was stopped as of 31/03/2010.
Subjects will be randomised (1:1:1) to one of three treatment arms:
1. 1 x 10 mg/day L-CsA and 1 x placebo/day
2. 2 x 10 mg/day L-CsA
3. 2 x placebo
Subj
Sponsors
PARI Pharma GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent provided prior to any screening procedure 2. Male or female, 12 years or older 3. Capable of self-administrating medications 4. Capable of understanding the purpose and risk of the study 5. Received an allogeneic haematopoietic stem cell transplantation 6. Has a diagnosis of bronchiolitis obliterans of grade 1, 2 or 3 based on forced expiratory volume in one second (FEV1) values according to protocol within one week prior to first investigational medicinal product administration (IMP) 7. Obtained a FEV1 value immediately before HSCT 8. Received within one week prior to first IMP administration the following immunosuppressive treatment and dosages for graft-versus-host-disease (GVHD) including bronchiolitis obliterans: 8.1. Tacrolimus 0.1 to 0.2 mg/kg/day adjusted to a target trough serum level (C0) of 5 to 15 µg/L 8.2. Prednisone 1 to 1.5 mg/kg/day for 2 to 6 weeks 9. Female patients with child bearing 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 treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include intra-uterine device (IUD), oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository) 10. Estimated life expectancy greater than 6 months
Exclusion criteria
Exclusion criteria: 1. Has an active invasive bacterial, viral or fungal infection within one week prior to first IMP administration 2. Received systemic maintenance immunosuppressive therapy for GVHD other than listed in the inclusion criteria within one week prior to first IMP administration 3. Received any systemic or topical cyclosporin within one week prior to first IMP administration and/or during the clinical trial 4. Received mechanical ventilation 5. Pregnant or breast feeding woman 6. Has known hypersensitivity to cyclosporin A 7. Has a serum creatinine value of more than 3 mg/dL 8. Unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol 9. Receipt of an investigational drug as part of a clinical trial within four weeks prior to first administration of IMP 10. Any co-existing medical condition that in the investigator?s judgement will substantially increase the risk associated with the subject's participation in the study 11. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures 12. Has been previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish an IMP dosage with the most favourable risk-benefit ratio for the prevention of BO in HSCT patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare efficacy and safety data from two different L-CsA doses versus placebo 2. To evaluate investigational medicinal product (IMP) pharmacokinetic (PK) data in bronchoalveolar lavage (BAL) and in whole blood samples | — |
Countries
Austria, Belgium, Denmark, France, Germany, Switzerland, United Kingdom
Outcome results
None listed