Uwe E. Berger

• MBA
• Guest Researcher at University of Innsbruck

Recommendations for a Clinically Relevant Effect Size for Phase III AIT Studies

Immunotherapy and tolerance induction, immunotherapy clinical, allergy treament, biomarkers

Rationale: PQ Grass 27600 SU ist ein modifiziertes Breitspektrum-Grasallergen-SCIT-Produkt, das ein MCT-MPL-Adjuvans-System verwendet. Die optimale kumulative Dosis von PQ Grass 27600 SU wurde in der Phase-II-Dosisfindung auf der Grundlage einer statistisch hochsignifikanten Dosis-Wirkungs-Beziehung mit Plateaubildung ermittelt. Wir berichten hier...

Rationale: PQ Grass 27600SU is a modified broad spectrum grass allergen SCIT product using an MCT-MPL adjuvant system. The optimal cumulative dose of PQ Grass of 27600SU was established in Phase II dose finding based on a highly statistically dose-response relationship with plateau formation. We report here the results of the RESONATE study conduct...

Q Grass 27600 SU is an innovative short-course allergen-specific SCIT product with 6 injections per treatment year. RESONATE is the first state-of-the-art Phase III SCIT trial to reach both a clinically relevant and statistically significant primary outcome and beneficial secondary efficacy results for an AIT product under the TAO.

PQ Grass 27600 SU is an innovative short-course allergen-specific SCIT product with 6 injections per treatment year. RESONATE is the first state-of-the-art Phase III SCIT trial to reach both a clinically relevant and statistically significant primary outcome and beneficial secondary efficacy results for an AIT product under the TAO.

The dataset presents a 43 year-long reanalysis of pollen seasons for three major allergenic genera of trees in Europe: alder (Alnus), birch (Betula), and olive (Olea). Driven by the meteorological reanalysis ERA5, the atmospheric composition model SILAM predicted the flowering period and calculated the Europe-wide dispersion pattern of pollen for t...

Hintergrund: Eine Pollenallergie kann die Lebensqualität von Menschen erheblich einschränken. In letzter Zeit haben Nahrungsergänzungsmittel bei Pollenallergikern an Bedeutung gewonnen. Doch es gibt nur wenige Forschungsdaten über die Wirksamkeit dieser Substanzen mit Bezug auf die empfundene Linderung von Allergiesymptomen. Insbesondere, wenn ein...

In rhinitis and asthma, several mHealth apps have been developed but only a few have been validated. However, these apps have a high potential for improving person‐centred care (PCC), especially in allergen immunotherapy (AIT). They can provide support in AIT initiation by selecting the appropriate patient and allergen shared decision‐making. They...

Zusammenfassung Hintergrund: Graspollenallergie ist global gesehen die häufigste Pollenallergie. Die Familie der Gräser (Poaceae) besteht aus vielen Gattungen und Arten von allergologischer Bedeutung, aber sie alle vereint eine einheitliche Pollenkornmorphologie. Phänologie ist der Schlüssel zur Unterscheidung der verschiedenen Taxa. Methoden: PubM...

Pollen allergy can have a significant impact on a person's quality of life. Recently, food supplements have gained in importance for persons suffering from pollen allergy. Still, there is not much research data on the efficacy of food supplements and the experienced relief, especially when choosing study designs that require less effort than random...

Ragweed (Ambrosia artemisiifolia), originally native to North America, was introduced to Europe in the 19th century through contaminated seed consignments. Since then, this invasive neophyte has rapidly spread, particularly in Eastern and Central Europe. In Austria, ragweed has been established since the 1970ies and has gained significant attention...

Hintergrund: Die Gräserpollensaison zeichnet sich durch eine besonders lange Dauer aus, umfasst in Europa die Monate Mai bis Juli, kann aber je nach Seehöhe beziehungsweise geografischer Lage variieren. Es werden im Speziellen drei Gräser vorgestellt, die durch eine spätere Blüte auffallen: Phragmites australis (Schilfrohr), Miscanthus spp. (Chinas...

Background Grass pollen allergy is the most common pollen allergy in the world. The grass family (Poaceae) consists of many genera and species of allergenic im- portance, but all share a uniform pollen grain mor- phology. Phenology is the key to discriminate differ- ent taxa. Methodology PubMed was used as the search engine. The publications found...

Background Grass pollen allergy is the most common pollen allergy in the world. The grass family (Poaceae) consists of many genera and species of allergenic importance, but all share a uniform pollen grain morphology. Phenology is the key to discriminate different taxa. Methodology PubMed was used as the search engine. The publications found were...

Background The measurement of pollen concentrations has been performed according to various protocols in recent decades. In all approaches the following questions were of importance: the positioning of the measuring device (whether at roof or nose level), the reliability as well as the comparability of measurements. Methods Current methods for pol...

Background The grass pollen season is characterized by a particularly long duration, covering the months May to July in Europe but can vary depending on the altitude and geographical location. Methods Three grass species whose flowering period takes place late in the season are discussed in detail: Phragmites australis (common reed), Miscanthus sp...

Background A modified grass allergen subcutaneous immunotherapy (SCIT) product with MicroCrystalline Tyrosine and monophosphoryl lipid‐A as an adjuvant system (Grass MATA MPL [PQ Grass]) is being developed as short‐course treatment of grass‐pollen allergic rhinitis (SAR) and/or rhinoconjunctivitis. We sought to evaluate the combined symptom and med...

Background: Allergic rhinitis (AR) is a major non-communicable disease that affects the health-related quality of life (HRQoL) of patients. However, data on HRQoL and symptom control in AR patients with comorbid asthma (AR+asthma) are lacking. Methods: In this multicentre, cross-sectional study, patients with AR were screened and administered ques...

Digital health is an umbrella term which encompasses eHealth and benefits from areas such as advanced computer sciences. eHealth includes mHealth apps, which offer the potential to redesign aspects of healthcare delivery. The capacity of apps to collect large amounts of longitudinal, real‐time, real‐world data enables the progression of biomedical...

An increasing prevalence of allergic diseases and asthma is registered worldwide. The numbers rise especially high in countries with a high degree of urbanization. An extensive literature search was performed to present the most important factors that influence the development of an allergy in an urban environment. Therefore, air pollution, with sp...

Background: Allergic rhinitis (AR) is a major non-communicable disease that affects the health-related quality of life (HRQoL) of patients. AR is significantly related to asthma also affecting HRQoL. However, data on HRQoL and symptom control in AR patients with comorbid asthma are lacking. Objective: To assess the differences of symptom control an...

Background Functional iron deficiency facilitates allergy development and amplifies the symptom burden in allergy sufferers. Previously micronutrients were selectively delivered to immune cells with beta-lactoglobulin as carrier (holoBLG), resulting in immune resilience and allergy prevention. Objective The clinical efficacy of a FSMP (food for sp...

A multitude of consequences from global warming and environmental pollution can already be seen for nature and humans. The continuous burning of fossil fuels leads to rising temperatures and rising water levels causing extreme weather phenomena like heat waves and flooding. Increasing levels of air pollution also cause adverse health effects. This...

In 2016, the highest birch ( Betula spp.) pollen concentrations were recorded in Kraków (Poland) since the beginning of pollen observations in 1991. The aim of this study was to ascertain the reason for this phenomenon, taking the local sources of pollen in Poland and long-range transport (LRT) episodes associated with the pollen influx from other...

The concept of treatment of an allergy with the offending allergen was introduced more than a century ago. Allergen immunotherapy (AIT) is the only disease modifying treatment of allergic diseases caused by inhalational allergens and insect venoms. Despite this, only few AIT products have reached licensure in the US or an official marketing authori...

In 2016, the highest birch (Betula spp.) pollen concentrations were recorded in Kraków (Poland) since the beginning of pollen observations in 1991. The aim of this study was to ascertain the reason for this phenomenon, taking the local sources of pollen in Poland and long-range transport (LRT) episodes associated with the pollen influx from other E...

Background Grass pollen allergy is the most widespread pollen allergy in the world. It still remains unknown in which aspects and in which extent symptoms from grass pollen allergy differ throughout the grass pollen season, although individual sensitization profiles of persons concerned are known for a long time. Methods The crowd-sourced symptom...

Ragweed Pollen Alarm System (R-PAS) has been running since 2014 to provide pollen information for countries in the Pannonian biogeographical region (PBR). The aim of this study was to develop forecast models of the representative aerobiological monitoring stations, identified by analysis based on a neural network computation. Monitoring stations wi...

Background The effectiveness of allergen immunotherapy (AIT) in seasonal and perennial allergic rhinitis (AR) depends on the definition of pollen exposure intensity or time period. We recently evaluated pollen and symptom data from Germany to examine the new definitions of the European Academy of Allergy and Clinical Immunology (EAACI) on pollen se...

Background: Pollen allergies affect a significant proportion of the population globally. At present, Web-based tools such as pollen diaries and mobile apps allow for easy and fast documentation of allergic symptoms via the internet. Objective: This study aimed to characterize the users of the Patient's Hayfever Diary (PHD), a Web-based platform...

The grass pollen season was monitored at the Biological Station Lake Neusiedl (Burgenland, Austria) during 2017, 2018 and 2019 by means of a Hirst-type volumetric pollen and spore trap. While the start, end, duration and peaks of the pollen seasons varied between the years, both showed a late occurrence of grass pollen in the air with more than 20...

Standard Hirst-type automated pollen and spore traps are used in aerobiology to assess ambient pollen concentrations with a focus on allergenic taxa, which are wind-pollinated. The relationship of insect to wind pollinated pollen concentrations has not been examined. We analysed the pollen data from the pollen seasons (1 April–31 August) 2008–2017...

BACKGROUND Pollen allergies concern a significant proportion of the population globally. Today, online tools such as pollen diaries and mobile applications allow an easy and fast documentation of allergic symptoms via the internet. OBJECTIVE This study aimed to characterize the users of the Patient´s Hayfever Diary, to apply different symptom scor...

Mobile health (mHealth) uses mobile communication devices such as smartphones and tablet computers to support and improve health‐related services, data and information flow, patient self‐management, surveillance, and disease management from the moment of first diagnosis to an optimized treatment. The European Academy of Allergy and Clinical Immunol...

Mugwort pollen allergy is frequent in parts of Europe. As mugwort pollen contains only one major allergen, Art v 1, which harbors only one T cell epitope, we employed mugwort pollen allergy as a model to study allergen-specific T cell responses. However, after 2004, we noticed a drastic decrease in the T cell responses to Art v 1 and eventually it...

Background Google Trends (GTs) is a web‐based surveillance tool that explores the searching trends of specific queries via Google. This tool proposes to reflect the real‐life epidemiology of allergic rhinitis and asthma. However, the validation of GTs against pollen concentrations is missing at the country level. Objectives In the present study, w...

The pollen spectra of air and surface soil samples from a rooftop (at 14 m) and from ground level (at 1.6 m) in the suburbs of Vienna (Austria) were compared. Two soil samples and two air samples were taken on four different days to account for possible differences: in winter when no pollination occurred (reference day), in spring during the main f...

A Parlagfű Pollen Riasztási Rendszer (Ragweed Pollen Alarm System (R-PAS)) 2014 óta nyújt információt a Pannon Biogeográfiai Régióban (PBR) lévő országok légterének pollenkoncentrációjáról. Tanulmányunk célja, egy, az aerobiológiai hálózat mérésein alapuló előrejelzési modell kifejlesztése neurális háló segítségével. A modell elkészítéséhez a PBR-b...

Background: It is recommended to position pollen monitoring stations on rooftop level to assure a large catchment area and to gain data that are representative for a regional scale. Herein, an investigation of the representativeness of pollen concentrations was performed for 20 pollen types in the pollen seasons 2015-2016 in Vienna for rooftop and...

Background: Allergy immunotherapy is still the only treatment of pollen allergy, providing a long-term effect. Clinical trials with pollen allergic patients are in need of validated, high quality pollen data and forecasts in order to grant comparability and to adhere to scientific standards. The aerobiological part of clinical trials remained hithe...

Background: This study compared a rapid home-based up-dosing schedule for sublingual immunotherapy (SLIT) drops containing tree pollen allergens with two previously established schedules. Furthermore, the clinical effect of the SLIT was investigated with respect to patients’ first pollen season under treatment. Methods: In this open-label, prospect...

Google Trends (GT) describes the variation of the relevant interest of internet searches toward medical conditions and related symptoms. Allergic rhinitis symptom levels result from the intensity of exposure to aeroallergens in combination with relevant medication use. We analyze data from Germany to examine the relationship between hay fever-relat...

Purpose of Review The definition of a pollen season determines the start and the end of the time period with a certain amount of pollen in the ambient air. Different pollen season definitions were used for a long time including the use of different terms for data and methods used to define a pollen season. Recently suggested pollen season definitio...

Poster presentation "Personal Allergy Symptom Forecasting System (PASYFO)"

Background: Online pollen diaries and mobile applications nowadays allow easy and fast documentation of pollen allergy symptoms. Such crowd-sourced symptom data provides insights into the development and the onset of a pollen allergy. Hitherto studies of the symptom load index (SLI) showed a discrepancy between the SLI and the total pollen amount o...

Background: Clinical efficacy of pollen allergen immunotherapy (AIT) has been broadly documented in randomized controlled trials. The underlying clinical endpoints are analysed in seasonal time periods predefined based on the background pollen concentration. However, any validated or generally accepted definition from academia or regulatory authori...

The drivers of spatial variation in ragweed pollen concentrations, contributing to severe allergic rhinitis and asthma, are poorly quantified. We analysed the spatiotemporal variability in 16-year (1995–2010) annual total (66 stations) and annual total (2010) (162 stations) ragweed pollen counts and 8 independent variables (start, end and duration...

Background: Google Trends (GT) searches trends of specific queries in Google, which potentially reflect the real-life epidemiology of allergic rhinitis. We compared GT terms related to ragweed pollen allergy in American and European Union countries with a known ragweed pollen season. Our aim was to assess seasonality and the terms needed to perfor...

Background The use of allergen immunotherapy (AIT) for allergic rhinitis and its clinical efficacy in clinical trials depends on the effective determination of pollen allergens exposure time‐periods. We evaluate pollen data from Germany to examine the new definitions on pollen season and peak pollen period start and end as proposed by the European...

Background Grasses release the most widespread aeroallergens with considerable sensitization rates, while different species produce several pollen concentration peaks throughout the season. This study analyzed the prevalence of grass species in three different European city areas and compared the flowering period of these species with daily pollen...

Background The GA²LEN chamber has been developed as a novel mobile allergen exposure chamber (AEC) allowing standardized multicenter trials in allergy. Hitherto, subjective nasal symptom scores have been the most often used outcome parameter, but in standardized modern trials objective parameters are preferred. Despite its practicability, the objec...

Ragweed Pollen Alarm System (R-PAS) has been running since 2014 to provide pollen information for countries in the Pannonian Biogeographical Region (PBR), being the epicentre of ragweed infestation in Europe. R-PAS was initiated by the Hungarian Aerobiological Network with the aim of creating 3-day forecast of daily pollen concentrations and visual...

Background: Birch pollen-related apple allergy is among the most prevalent food allergies in adolescent/adult individuals and mainly results from sensitization to the major birch pollen allergen Bet v 1 and subsequent cross-reaction with the apple protein Mal d 1. However, specific immunotherapy with birch pollen has inconsistent effects on apple...

In a recently published paper (Pfaar et al., 2016), a Task Force of the Immunotherapy and Aerobiology and Pollution Interest Groups of the EAACI suggested specific criteria for the definition of pollen exposure times for three types of pollen events: (a) Pollen Season (PS) start and end, (b) high pollen season (or Peak Pollen Period-PPP) start and...

Aim: The European Commission Cooperation in Science and Technology (COST) Action FA1203 “SMARTER” aims to make recommendations for the sustainable management of Ambrosia across Europe and for monitoring its efficiency and cost effectiveness. Present study analyses geographic and temporal variations in atmospheric Ambrosia pollen, with the goal of p...

The pollen content of the air in an office was assessed together with the dust on the floor and on the desktops as well as the pollen content outside of the building on rooftops and at ground level. The whole pollen spectrum was evaluated (35 different pollen types) with focus on the major aeroallergens. The air samples were measured with Hirst-typ...

Background: Pollen forecasts are highly valuable for allergen avoidance and thus raising the quality of life of persons concerned by pollen allergies. They are considered as valuable free services for the public. Careful scientific evaluation of pollen forecasts in terms of accurateness and reliability has not been available till date. Objective: T...

The aim of this study was to investigate possible effects of landscape design on the IgE sensitization profile toward inhalant allergens in patients with respiratory allergy from Uzbekistan where green areas have been changed during the last two decades by a State program. Sera from two different generations of Uzbek (n=58) and, for control purpose...

Pollen information is of great importance in the everyday life of pollen allergy sufferers and substantially supports in allergen avoidance. Nowadays, pollen information is distributed also via mobile applications (apps). Those apps provide different features, but should conform to a catalogue of criteria, that are essential for users. Those criter...

Pollen information as such is highly valuable and was considered so far as a self-evident good free for the public. The foundation for reliable and serious pollen information is the careful, scientific evaluation of pollen content in the air. However, it is essential to state and define now the requirements for pollen data and qualifications needed...

Background: Clinical efficacy of pollen allergen immunotherapy has been broadly documented in randomized controlled trials. The underlying clinical endpoints are analysed in seasonal time periods pre-defined on the basis of the background pollen concentration. However, any validated or generally accepted definition from academia or regulatory auth...

Background: Grasses (Poaceae) are one of the largest plant families and are distributed worldwide. Grass pollen allergy is one of the most important pollen allergies affecting large parts of the population worldwide. The grass pollen season itself is special since it is caused by the flowering of various grass species that present unique profiles...

Background: Field clinical trials of pollen allergy are affected by the impossibility of predicting and determining individual allergen exposure because of many factors (eg, pollen season, atmospheric variations, pollutants, and lifestyles). Environmental exposure chambers, delivering a fixed amount of allergen in a controlled environmental settin...

COST SMARTER aims to develop new innovative solutions for the the sustainable management of Ambrosia artemisiifolia L. (ragweed) in Europe and to assess their cost- effectiveness. Several recent studies undertaken by members of COST SMARTER have examined temporal and spatial variations in airborne Ambrosia pollen at different scales, which can be u...

Background The Austrian pollen information service distributes pollen forecasts and offers various options (webpages, a mobile “Pollen” app, interviews for newspapers, radio, TV and information for the press agency) to support and inform pollen allergy sufferers in Austria in the best way to help to avoid their allergen. These services are well rec...

Background: Idiopathic pulmonary fibrosis (IPF) is a chronic progressive multifactorial disease with limited treatment options.