Trial document




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  DRKS00000184

Trial Description

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Title

Influence of inhaled Aviptadil on the immunologic activity of alveolar macrophages in sarcoidosis

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Trial Acronym

AVISARCO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with histologically proven sarcoidosis and active disease by clinical judgement are elegible for inclusion in this study. The aim of the study is to test whether a short treatment period with Aviptadil inhalation changes cellular responses in the lung. Therefore, patients will receive Aviptadil by inhalation. Aviptadil is synthetically produced vasoactive intestinal peptide (VIP). VIP is naturally occuring neuropeptide of the human body. In animal and in vitro experiments it was shown that VIP changes the immune response and thereby influences disease processes.

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Brief Summary in Scientific Language

Patients with histologically proven active pulmonary sarcoidosis were included in the study evaluating the inhalative Aviptadil (synthetic vasoactive intestinal peptide, VIP). The patients will receive 50 µg synthetic VIP (Aviptadil, mondoBIOTECH) four times daily by inhalation via an ultrasonic nebulizer (Optineb®, Nebu-Tec, Elsenfeld, Germany) for 28 days. At day 1, before the first inhalation of VIP, vital signs, pulmonary function, CO diffusion capacity, laboratory chemistry and bronchoalveolar lavage will be obtained. After that, the patients will be advised in detail about the inhalation method and will receive the study medication. The baseline procedures of day 0 will be repeated at the end of treatment period.
BAL cell differential counts will be obtained. In addition, BAL cell cytokine production and surface marker expression will be analyzed by ELISA and flow cytometry.

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Organizational Data

  •   DRKS00000184
  •   2009/08/19
  •   2005/04/19
  •   no
  •   Approved
  •   178/04, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2004-003759-38 
  •   UKF000356  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   D86.0 -  Sarcoidosis of lung
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Interventions/Observational Groups

  •   open, uncontrolled; 50 microgramm Aviptadil four times daily per inhalation
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

Spontaneous production of TNF-alpha by BAL cells

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Secondary Outcome

a) changes in TGF beta1, TGF beta2, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10 and IFN-gamma; expression in alveolar macrophages;
b) changes in the expression of the CD1a, CD1c, CD11a, CD11b, CD11c, CD18, CD20, CD40, CD54, CD58, CD68, CD80, CD83, CD86, CD123, HLA-DR cell surface marker of the alveolar macrophages of sarcoidosis patients;
c) changes in the quality of life as recorded in appropriate questionnaire forms (SF36, EuroQol, St. George's Respiratory Questionnaire)
d) clinical deterioration;
e) Safety parameters
* Vital signs
* Body weight
* Tolerance

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2006/05/29
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Diagnosis: clinically active pulmonary sarcoidosis, with or without ocular sarcoidosis based on clinical history, and lung or intrathoracic lymph node biopsy, consistent with sarcoidosis with other causes of granuloma ruled out
*Aged above 18 years
*Written consent
*Adequate contraception in female patients of childbearing age
*Negative pregnancy test

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Exclusion Criteria

*Lack of consent
*Pregnancy and lactation
*Presumed non-cooperativeness
*Patients outside the stipulated age range
*Malignant diseases in anamnesis
*Legal incapacity
*Parallel participation in another clinical trial
*Clinical instability
*Abnormal breathing

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Addresses

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    • mondoBIOTECH Laboratories Anstalt
    • mondoBIOTECH 
    • Austrasse 79, Europapark
    • 9490  Vaduz
    • Switzerland
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    • Universitätsklinikum Freiburg, Abteilung für Pneumologie
    • Ms.  Dr. med.  Antje  Prasse 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Pneumologie
    • Mr.  Prof. Dr. med.  Joachim  Müller-Quernheim 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • mondoBIOTECH Laboratories Anstalt
    • Austrasse 79, Europapark
    • 9490  Vaduz
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2009/09/30
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* This entry means the parameter is not applicable or has not been set.