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

February 6, 2007 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

7

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wim Van Der Bij, MD, PhD
  • Phone Number: +31 50 3616161

Study Contact Backup

  • Name: Huib Kerstjens, MD, PhD
  • Phone Number: +31 50 3616161

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • University Medical Center Groningen
        • Principal Investigator:
          • Wim Van Der Bij, Md, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in Forced Expiratory Volume in 1 second before and after intervention
Amount of lung deposition of cyclosporine A
Systemic uptake of Cyclosporine A

Secondary Outcome Measures

Outcome Measure
Kidney function (GFR and serum creat)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Gerrit Zijlstra, Pharmacist, University of Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Estimate)

February 7, 2007

Last Update Submitted That Met QC Criteria

February 6, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSA-DPI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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