TASK FORCES for 2011:

-. Task Force on “European Survey on Systemic Adverse Reactions due to Allergen Immunotherapy in real life setting”

TF-coordinator: MA Calderon
Start date: 2011
Finish dates:
• 2012 (Phase I): Survey design
• 2013 (Phase II): pilot-study (4 European countries)
• 2016 (Phase III): Pan-European survey

Rationale: To date, clinical trials on SIT are based on carefully controlled clinical protocols in experimental conditions with pre-defined patient numbers and therefore specific information on side-effects. Therefore, the aim of this prospective survey is to collect on all adverse reactions which may occur on daily practice in the allergy clinics.

Main objective:
To describe the safety profile of immunotherapy, prospectively, in real life setting in Europe.
To estimate the incidence of clinically relevant systemic adverse reactions due to immunotherapy.
To determine the number of systemic, anaphylactic and life-threatening allergic reactions occurring per patient and per treatment-year.

-. Task Force on “Evaluation of adherence to SCIT and SLIT in Europe (PASTE-study)”

Coordinators: Gianenrico Senna and Giovanni Passalacqua
Start-date: 2011; Finish-date: 2014

Rationale: A good therapy-adherence of patients is essential for the efficacy of both SLIT and SCIT. However, only few clinical reports focus on adherence and underlying factors influencing this issue.

Main objective of this project is:
To evaluate and compare the adherence rate to SLIT and SCIT in Europe and search for the reasons underlying its lack of adherence.
About 100 members from EAACI will be requested to join this study and follow their SIT prescriptions each 4 months and in case of lack of adherence, address the possible reason: lack of efficacy, cost, tolerance, GP acceptance or any other reason. This study will be conducted electronically.

-. Task Force on “Standardization of (Primary) Clinical Outcomes for Clinical Trials in SIT”

TF-Coordinators: Oliver Pfaar and Sabina Rak
Start-date: 2011
Finish date: 2012

Rationale: Generally accepted and authoritative national and international guidelines are still lacking with respect to the assessment of the therapeutic effects of SIT by using clearly-defined symptom- and medication-scores. Therefore, the aim of the task-force will be to propose a position statement clearly defining how symptoms and medications should be assessed, analysed and adequately weighted in prospective clinical trials on both SLIT and SCIT.

Main objectives:
To gather all scoring-systems so far used in trials on SLIT and SCIT.
To l produce a rostrum paper to be published in Allergy.

-. Project on “Seasonal Allergic Rhinitis: In search of the cut-off points”

Coordinator: Glennis Scadding and Moises Calderon
Start date: 2011
Finish date: 2012

Rationale: The evaluation of patient’s assessments of any particular therapeutic intervention during a clinical trial is very important. This can be measured using the validated RQLQ.

Main objective:
To identify the cut-off point between adequately and inadequately controlled rhinoconjunctivitis/rhinitis using the mini Rhinitis-Quality-of-Life-Questionnaire (RQLQ).
Members of the IT IG and EAACI ENT Section will be requested their voluntary participation to take part in a “one” page electronic survey.
Already positive approval has been given by members of the EAACI ExCom.

-. Project “Semantics in SIT and MedDRA terminology for adverse reactions due to SIT”

Coordinator: Pascal Demoly and Moises Calderon
Start date: 2011
Finish date: 2012

Rationale: Current semantic use to characterize allergen immunotherapy and terminology for adverse reactions is heterogeneous depending on the countries and/or the scientific societies.

Main objective:
To create a common language for all audiences regarding immunotherapy and identify semantic keys to reinforce the impact of communication on allergy immunotherapy. To create a harmonised MedDRA based terminology for the report of adverse reactions after SIT in a real life setting.

-. Task force on “Contraindications of SIT”

Coordinator: Constantinos Pitsios
Start date: 2011
Finish date: 2012

Rationale: Despite the large number of papers published on SCIT and SLIT, there is still no common agreement on the “contra-indications” for SIT.

Main objective: To collect and compare clinical data on the effect of SIT in the known contraindications.
A systematic literature search will be performed to re-assess SIT contraindications and adapt them to current situation of different diseases, co-morbidities and certain drugs.