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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
Sponsor:
Information provided by:
University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Lung Transplantation Bronchiolitis Obliterans Drug: Cyclosporine A dry powder inhalation (Drug) Early Phase 1

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  (Clinical Trial)
Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in Forced Expiratory Volume in 1 second before and after intervention
  2. Amount of lung deposition of cyclosporine A
  3. Systemic uptake of Cyclosporine A

Secondary Outcome Measures :
  1. Kidney function (GFR and serum creat)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Wim Van Der Bij, MD, PhD +31 50 3616161
Contact: Huib Kerstjens, MD, PhD +31 50 3616161

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Principal Investigator: Wim Van Der Bij, Md, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Gerrit Zijlstra, Pharmacist University of Groningen

ClinicalTrials.gov Identifier: NCT00378677     History of Changes
Other Study ID Numbers: CSA-DPI
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: February 7, 2007
Last Verified: February 2007

Keywords provided by University Medical Center Groningen:
Powder inhalation
Side effects
Nephrotoxicity
Calcineurin inhibitor
Bronchiolitis obliterans syndrome
Forced Expiratory Volume

Additional relevant MeSH terms:
Respiratory Aspiration
Bronchiolitis
Bronchiolitis Obliterans
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors