Generic Immunosuppressive Drugs After Lung Transplantation

Study Overview
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Brief Summary
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Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation

Detailed Description
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Solid organ transplant recipients are treated with immunosuppressive drugs to prevent rejection of their grafts. The most frequently important maintenance immunosuppressive drugs in Europe are calcineurin inhibitors. For a number of these compounds drug patents have expired in recent years and generic formulations have entered the market. There is considerable debate regarding the efficacy and safety of generic drug substitution in solid organ recipients.

Official Title
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Generic Immunosuppressive Drugs After Lung Transplantation - a Crosssectional Observational Study by Patient Questionnaire

Conditions
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Immunosuppressive After Lung Transplantation

Intervention / Treatment
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* Other: patient questionnaire (tablet pc based)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients after lung transplantation (single, double or combined) informed consent patient with an immunosuppressive therapy with tacrolimus or ciclosporin Exclusion Criteria: immunosuppressive therapy without calcineurin inhibitors need for isolation (Colonization with multi. or pan resistant organisms e.g. methicillin-resistant staph. aureus[MRSA), B. cenocepacia) limited German language skills or other reasons which might impair patient communication or computer handling

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: patient questionnaire (tablet pc based)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use of generic immunosuppressive drugs |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcineurin inhibitor through levels | Frequency of calcineurin inhibitor through levels in target range between generic and original immunosuppressive drugs during last 6 months | baseline, retrospective 6 months | 
| Dose of calcineurin inhibitors | Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire | baseline | 
| Therapy adherence | Therapy adherence between generic and original immunosuppressive drugs. Adherence will be measured by a 5 item Likert scale covering self-monitoring, generla health perception, contacts, nutrition/exercise compliance and adherence to immunosuppression. | baseline | 
| Satisfaction with immunosuppression | Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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generic immunosuppressive