NCT00378677

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
Last Updated

February 7, 2007

Status Verified

February 1, 2007

First QC Date

September 20, 2006

Last Update Submit

February 6, 2007

Conditions

Lung TransplantationBronchiolitis Obliterans

Keywords

Powder inhalationSide effectsNephrotoxicityCalcineurin inhibitorBronchiolitis obliterans syndromeForced Expiratory Volume

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Kidney function (GFR and serum creat)

Interventions

Cyclosporine A dry powder inhalation (Drug)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Bronchiolitis ObliteransBronchiolitis Obliterans Syndrome

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesOrganizing PneumoniaGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Gerrit Zijlstra, Pharmacist

    University of Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wim Van Der Bij, MD, PhD

CONTACT

+31 50 3616161

Huib Kerstjens, MD, PhD

CONTACT

+31 50 3616161

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

February 1, 2007

Last Updated

February 7, 2007

Record last verified: 2007-02

Locations

NL(1)