Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
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|ClinicalTrials.gov Identifier: NCT00378677|
Recruitment Status : Unknown
Verified February 2007 by University Medical Center Groningen.
Recruitment status was: Recruiting
First Posted : September 21, 2006
Last Update Posted : February 7, 2007
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplantation Bronchiolitis Obliterans||Drug: Cyclosporine A dry powder inhalation (Drug)||Early Phase 1|
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 (Clinical Trial)|
|Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome|
|Study Start Date :||February 2007|
- Change in Forced Expiratory Volume in 1 second before and after intervention
- Amount of lung deposition of cyclosporine A
- Systemic uptake of Cyclosporine A
- Kidney function (GFR and serum creat)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378677
|Contact: Wim Van Der Bij, MD, PhD||+31 50 3616161|
|Contact: Huib Kerstjens, MD, PhD||+31 50 3616161|
|University Medical Center Groningen||Recruiting|
|Principal Investigator: Wim Van Der Bij, Md, PhD|
|Principal Investigator:||Gerrit Zijlstra, Pharmacist||University of Groningen|