UnknownEarly Phase 1

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

Netherlands7 participantsStarted 2007-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Forced Expiratory Volume in 1 second before and after intervention

Amount of lung deposition of cyclosporine A

Systemic uptake of Cyclosporine A

Trial details

NCT IDNCT00378677

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Wim Van Der Bij, MD, PhD

+31 50 3616161

View on ClinicalTrials.gov More Lung Transplantation trials