L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) Patients

NCT01334892 | Terminated Phase 2 DMC

• 3 other identifiers: 12011.2012008-003800-73ISRCTN66069132
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Immunosuppression is a key intervention in patients with solid organ transplant and is usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine, mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation are poor when compared with those after heart, kidney, or liver transplantation, with a survival rate of only 55% for recipients of lung transplants. Additional application of aerosolised L-CsA should suppress T-cell activation in the lung tissue and subsequently BOS development. The overall purpose of this phase-II/III study is to obtain efficacy and safety data of L-CsA in the prevention of BOS.

Conditions

Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

• The primary objective is to compare cumulative BOS-free survival of patients recieving L-CsA or placebo.

  BOS stage 1 and higher is considered as BOS for the primary endpoint.

  2 years

Secondary Outcomes (1)

• Cumulative mean incidence of BOS 12, 18 and 24 months after first IMP administration

  2 years

Study Arms (2)

L-CsA

ACTIVE COMPARATOR

Twice daily inhalation of 2.5 ml/10 mg L-CsA for 96 weeks

Drug: Cyclosporine Inhalation Solution

L-CsA placebo

PLACEBO COMPARATOR

Twice daily inhalation of 2.5 ml aerosolised placebo (carrier) for 96 weeks (24 months)

Drug: Cyclosporine Inhalation Solution

Interventions

Cyclosporine Inhalation Solution DRUG

Cyclosporin for inhalation twice daily

L-CsA; L-CsA placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's written informed consent
• Received a single lung, bilateral lung or heart/lung transplantation between 6 weeks and 26 weeks prior to first IMP administration.
• Male or female, 18 years of age
• Capable of self-administration of medications
• Capable of understanding the purpose and risk of the clinical trial
• Received the following immunosuppressive agents and dosages for maintenance therapy:
• Tacrolimus and
• Mycophenolate mofetil (MMF) 1 to 3 g/day and
• Prednisone or any other steroid therapy; tapered down
• Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
• Estimated life expectancy \> 6 month

You may not qualify if:

• Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher
• Any active invasive bacterial, viral or fungal infection
• Received any systemic or topical ciclosporin A within
• Received any systemic or topical Rosuvastatin
• Current mechanical ventilation
• Received a lung re-transplantation
• Pregnant or breast feeding woman
• Has known hypersensitivity to ciclosporin A
• Has a serum creatinine value of more than 265 µmol/L (3 mg/dL)
• Unlikely to comply with visits, inhalation procedures or spirometric measurements
• Receipt of an investigational drug within 4 weeks prior to first administration of IMP
• Any co-existing medical condition that in the investigator's judgement
• Psychiatric disorders or altered mental status
• Patient was previously enrolled in the present clinical trial

Sponsors & Collaborators

• Pari Pharma GmbH: lead

Study Sites (1)

PARI Pharma GmbH

Gräfelfing, 82166, Germany

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: December 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

DE (1)