Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome

NCT ID: NCT00378677

Last Updated: 2007-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28

Brief Summary

The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.

Detailed Description

Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndrome, BOS) a rejection risc remains. To effectively treat BOS high doses of calcineurin inhibitors are necessary. On the other hand these high doses lead te serious side effects. The search for a balance between effectiveness and side effects leads to dose adjustments. Ultimately, chronic rejection is unstoppable.

In order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. The only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. Indeed, this has been extensively investigated at the University of Pittsburgh (lead investigator Iacono).

The intervention in the Pittsburgh trials existed of nebulization of Cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable.

The investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine A. The effectiveness is measured by comparing the Forced Expiratory Volume in 1 second (FEV1) before and after the intervention.

Conditions

Lung Transplantation; Bronchiolitis Obliterans

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cyclosporine A dry powder inhalation (Drug)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent
• Primary lung transplant
• Tacrolimus as maintenance therapy
• Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1<80% of baseline
• At least 3 months after last usual BOS intervention
• Declining FEV1 after last usual BOS intervention

Exclusion Criteria

• Cyclosporine as maintenance therapy
• Bronchiolitis Obliterans Syndrome 0: FEV1>80%
• Renal failure: Glomerular Filtration Rate < 30 ml/min
• Chronic airway infections
• Clinical stability
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Principal Investigators

Gerrit Zijlstra, Pharmacist

Role: PRINCIPAL_INVESTIGATOR

University of Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Wim Van Der Bij, MD, PhD

Role: CONTACT

+31 50 3616161

Huib Kerstjens, MD, PhD

Role: CONTACT

+31 50 3616161

Other Identifiers

CSA-DPI

Identifier Type: -

Identifier Source: org_study_id