Trial document
DRKS00005069
Trial Description
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
Trial Acronym
LARGE
URL of the Trial
[---]*
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.
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.
Organizational Data
- DRKS00005069
- 2013/07/04
- [---]*
- no
- Approved
- F-2013-20, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
Secondary IDs
- [---]*
Health Condition or Problem studied
- J30.1 - Allergic rhinitis due to pollen
- J30.3 - Other allergic rhinitis
Interventions/Observational Groups
- Routine treatment with specific immunotherapy (AVANZ® or GRAZAX® or SLIToneULTRA®)
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Treatment
- Single (group)
- N/A
- No
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.
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
Countries of Recruitment
- Germany
Locations of Recruitment
- Doctor's Practice
Recruitment
- Actual
- 2013/06/17
- 1500
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 5 Years
- no maximum age
Additional Inclusion Criteria
Routine treatment with specific immunotherapy (AVANZ®/GRAZAX®/SLIToneULTRA®)
Exclusion Criteria
Contraindications of specific immunotherapy
Addresses
-
start of 1:1-Block address primary-sponsor
- ALK-Abelló Arzneimittel GmbH
- Griegstrasse 75, Haus 25
- D-22763 Hamburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- ALK-Abelló Arzneimittel GmbH, Clinical Development
- Mr. Dr. rer. nat. Hendrik Wolf
- Griegstrasse 75, Haus 25
- D-22763 Hamburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 40 703845-342
- +49 40 70384555-30
- hendrik.wolf at alk.net
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- ALK-Abelló Arzneimittel GmbH, Clinical Development
- Mr. Dr. Hendrik Wolf
- Griegstraße 75, Haus 25
- D-22763 Hamburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 40 703845-342
- +49 40 70384555-30
- hendrik.wolf at alk.net
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- ALK-Abelló Arzneimittel GmbH
- Griegstrasse 75, Haus 25
- D-22763 Hamburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2018/05/08
Trial Publications, Results and other Documents
- [---]*