Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Transplantation Bronchiolitis Obliterans |
Drug: Cyclosporine A dry powder inhalation (Drug) |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome |
- 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)
| Estimated Enrollment: | 7 |
| Study Start Date: | February 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Wim Van Der Bij, MD, PhD | +31 50 3616161 | |
| Contact: Huib Kerstjens, MD, PhD | +31 50 3616161 |
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands | |
| Principal Investigator: Wim Van Der Bij, Md, PhD | |
| Principal Investigator: | Gerrit Zijlstra, Pharmacist | University of Groningen |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00378677 History of Changes |
| Other Study ID Numbers: | CSA-DPI |
| Study First Received: | September 20, 2006 |
| Last Updated: | February 6, 2007 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by University Medical Centre Groningen:
|
Powder inhalation Side effects Nephrotoxicity |
Calcineurin inhibitor Bronchiolitis obliterans syndrome Forced Expiratory Volume |
Additional relevant MeSH terms:
|
Bronchiolitis Obliterans Respiratory Aspiration Bronchiolitis Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Bronchitis Bronchial Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Cyclosporins |
Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013