Trial document



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  DRKS00005069

Trial Description

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Title

Longitudinal non-interventional observational study on Adherence, safety and tolerability of AVANZ® in adults and GRAZAX® and SLIToneULTRA® in adults and children (5 – 17 years) in patients with allergic Rhinoconjunctivitis in GErmany

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Trial Acronym

LARGE

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URL of the Trial

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Brief Summary in Lay Language

Systematically recorded data on the conformity of patient behaviour to accepted treatment recommendations (adherence) and the treatment continuance over the planned overall duration of 3 years (persistence) for subcutaneous, tablet and sublingual specific immunotherapy with different preparations (AVANZ®/GRAZAX®/SLIToneULTRA®) in real-life are currently not available.
Aim of the study is, therefore, to record data on adherence during a 3-year treatment with subcutaneous specific immunotherapy (SCIT, AVANZ®) in adults, with grass immunotherapy tablet (grass AIT, GRAZAX®) and with drop-based sublingual immunotherapy (SLIT, SLIToneULTRA®) in adults and children (5 – 17 years) during routine treatment.
For that purpose the physician records the administrations of specific immunotherapy performed in his clinic during the 3-year treatment period and adverse events, if applicable and assesses the adherence and persistence of the patient during regular visits every 3 months.
The patient enters data in a patient questionnaire once a year for allergies with all year round symptoms and additionally for pollen allergies during the pollen season. The questionnaire consists of questions on his functional status, labor productivity and health care, of assessments on his benefit of therapy and on his satisfaction with treatment and on his symptoms.

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Brief Summary in Scientific Language

A non-interventional observational longitudinal study in adults (AVANZ®) and adults and children aged 5 – 17 years (GRAZAX®, SLIToneULTRA®) in order to obtain information about use of AVANZ®, GRAZAX®, and SLIToneULTRA® over 3 years of treatment in a real life setting. The number of patients to be included in the study will add to the existing safety data for the products.

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Organizational Data

  •   DRKS00005069
  •   2013/07/04
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  •   no
  •   Approved
  •   F-2013-20, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   J30.1 -  Allergic rhinitis due to pollen
  •   J30.3 -  Other allergic rhinitis
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Interventions/Observational Groups

  •   Routine treatment with specific immunotherapy (AVANZ® or GRAZAX® or SLIToneULTRA®)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Adherence / persistence during the planned 3-year course of specific immunotherapy quantified by the proportion of completers considering treatment discontinuations due to adverse events or reasons definitely not related to treatment, frequency of re-prescriptions.

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Secondary Outcome

Safety and tolerability during the planned 3-year course of treatment, application of measures to increase compliance, predictive factors for adherence/persistence, correlation with therapeutic effect, patient questionnaire for health care research

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/06/17
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   no maximum age
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Additional Inclusion Criteria

Routine treatment with specific immunotherapy (AVANZ®/GRAZAX®/SLIToneULTRA®)

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Exclusion Criteria

Contraindications of specific immunotherapy

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Addresses

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    • ALK-Abelló Arzneimittel GmbH
    • Griegstrasse 75, Haus 25
    • D-22763  Hamburg
    • Germany
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    • ALK-Abelló Arzneimittel GmbH, Clinical Development
    • Mr.  Dr. rer. nat.  Hendrik  Wolf 
    • Griegstrasse 75, Haus 25
    • D-22763  Hamburg
    • Germany
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    • ALK-Abelló Arzneimittel GmbH, Clinical Development
    • Mr.  Dr.  Hendrik  Wolf 
    • Griegstraße 75, Haus 25
    • D-22763  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • ALK-Abelló Arzneimittel GmbH
    • Griegstrasse 75, Haus 25
    • D-22763  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/08
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Trial Publications, Results and other Documents

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