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REGISTRO ASMA GRAVE - Italian Registry Severe Asthma
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Studio osservazionale

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L’asma è una sindrome ostruttiva respiratoria eterogenea, con differenti fenotipi clinici che influenzano la variabilità della risposta dei pazienti alla terapia. Si tratta di una patologia che tuttora è ancora sottodiagnosticata e non adeguatamente trattata, eppure può essere responsabile di crisi ostruttive respiratorie a volte anche gravi, di near fatal asthma e di mortalità, che colpisce purtroppo circa 500 soggetti all’anno nel nostro Paese (dati ISTAT). E’ una mortalità frequentemente ingiustificata dal punto di vista clinico-terapeutico, perché è generalmente da collegarsi ad un non corretto trattamento di molti pazienti, soprattutto di età giovanile.

D’altra parte, è noto che nel nostro Paese oltre la metà dei soggetti con asma persistente assume un trattamento inadeguato, in senso quantitativo, di farmaci antiinfiammatori e non l’assume quotidianamente come è indicato da tutte le linee guida o, peggio ancora, si cura solo con broncodilatatori come i β2 short acting.

L’asma, sia a substrato allergico che non allergico, rappresenta per la sua prevalenza e gravità un problema non solo sanitario ma anche sociale ed economico, soprattutto per il costo elevato delle forme di asma grave.

Queste espressioni patologiche impongono terapie continuative e controlli periodici con indirizzi terapeutici mirati (steroidi/farmaci biologici, ecc.).

C’è, in breve, necessità di una migliore fenotipizzazione, ovvero l’analisi delle proprietà fisiche e biochimiche dei pazienti con asma grave ed è altresì importante un follow up di queste manifestazioni cliniche ostruttive.

Attraverso la registrazione dei casi di asma grave seguiti presso centri specialistici italiani di pneumologia e allergologia, ci si propone di individuare i fattori di rischio nella popolazione italiana, fenotipizzare i pazienti asmatici sulla base di parametri biologici (prick test/RAST, eosinofilia, FeNO) e di seguire nel tempo i pazienti non responsivi a terapia una volta fenotipizzati, anche al fine di eseguire in futuro studi clinico-farmacologici appropriati.

All’interno di questo contesto, AAIITO e AIPO attraverso il REGISTRO ASMA GRAVE, desiderano raccogliere dati di “real-life” relativi ai pazienti affetti da questa patologia al fine di approfondire importanti peculiarità cliniche, diagnostico-terapeutiche e sociali dell’Asma Grave con le sue varie espressioni fenotipiche.

studio MISTRAL
An Italian, 3-year, MultIcenter, proSpective, cohorT observAtional study to evaluate pharmacologicaL management in COPD patients”COPD
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American Thoracic Society 2018 International Conference, May 18-23, 2018 - San Diego, CA
B40
Burden of COPD in Italian Women and Men: Results from the MISTRAL Study
R. Vincenti1, M. C. De Leonardis2, G. Di Marco3, M. Marino4, M. Dottorini5, M. Bartezaghi6, P. A. Porpiglia6, P. Morini6

1U.O.C.A. Pneumologia Ospedale di Livorno - Toscana (Italy),
2Pneumologia-A.O. Spedali Civili - Brescia (Italy),
3Servizio Territoriale Pneumologia-ASP Trapani - Cittadella della salute - Erice (Italy),
4UOS Pneumologia III e IV distretto-Ambulatorio Territoriale ASL RM B - Roma (Italy),
5Servizio Riabilitazione Respiratoria Pneumologia Territoriale-AUSL Umbria 1 - Ellera di Corciano (Italy),
6Novartis Farma - Origgio (Italy)

Leggi l'abstract su American Journal of Respiratory and Critical Care Medicine 2018, Volume 197

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Pharmacological approach and adherence to treatment recommendations in frequently and non-frequently exacerbating COPD patients from Italy: MISTRAL - The prospective cohort, observational study. 

September 2018. ​Pulmonary Pharmacology & Therapeutics 53. DOI:10.1016/j.pupt.2018.09.001

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Abstract

Background: Several documents and guidelines provide recommendations for effective management of COPD patients. However, there is often a significant imbalance between recommended treatment of COPD patients and the actual care provided both in primary care and specialty setting. This imbalance could result in a significant negative impact on patients' health status and quality of life, leading to increased hospitalisations and health resource utilisation in COPD patients METHODS: MISTRAL was an observational, longitudinal, prospective cohort study, designed to assess the overall pharmacological approach of COPD in routine clinical practice in Italy. Eligible patients were divided into two cohorts based on their exacerbation history in the year prior to the enrolment, frequent exacerbators (FEs; ≥2 exacerbations), and non-frequent exacerbators (NFEs; ≤1 exacerbation). The primary objective was to assess adherence to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 treatment recommendations in FEs and NFEs at baseline and follow-up visits RESULTS: Of the 1489 enrolled patients, 1468 (98.6%; FEs, 526; NFEs, 942) were considered evaluable for analyses. At baseline, 57.8% of patients were treated according to GOLD 2011 recommendations; a greater proportion of FEs were treated according to GOLD recommendations, compared with NFEs patients at baseline (77.1% versus 46.7%; P < 0.0001), and all study visits. At baseline, GOLD group D patients were the most adherent (81.2%) to treatment recommendations, while group A patients were the least adherent (30.3%) at baseline, attributed mainly to overuse of inhaled corticosteroids in less severe GOLD groups. Triple therapy with long-acting muscarinic antagonist (LAMA) + long-acting β2-agonist/inhaled corticosteroid (LABA/ICS) was the most frequent prescribed treatment at all study visits, irrespective of patient's exacerbation history. Changes in treatment were more frequent in FEs versus NFEs CONCLUSIONS: The Mistral study reports a scarce adherence to the GOLD 2011 treatment recommendations in routine clinical practice in Italy. The adherence was particularly low in less severe, non-frequent exacerbating patients mostly for ICS overuse, and was higher in high-risk, frequent exacerbating COPD patients.

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ATS 2018 INTERNATIONAL CONFERENCE - MAY 18-23, SAN DIEGO
PA960
Adherence to GOLD recommendations in Italian COPD patients stratified by GOLD groups A–D: the MISTRAL study

Conclusions
•• Findings from the MISTRAL study highlight the lack of adherence (approximately 55%) to the GOLD 2011 recommendations in routine clinical practice in Italy for the management of COPD patients
•• Prescriptions in GOLD group A were the least adherent to recommendations mainly due to ICS overuse in less severe patients
•• Regarding GOLD group D, the higher adherence to GOLD 2011 could be a consequence of a closer attention to recommendations in the more severe
patients but also potentially due to ICS overuse that by chance becomes appropriate for these patients

Increase of Chenopodiaceae pollinosis
caused by changes due to human activities

XXX Congress of the European Academy of Allergy - Istanbul, Turkey 11‐15 June 2011
383
Increase of chenopodiaceae pollinosis caused by changes in territory due to human activities
Bruno, Marco1 ; Di Marco, Giuseppe2
1 Lofarma S.p.A., Medical Department, Milan, Italy;
2 Ospedale di Salemi - ASP9 Trapani, Pneumology Service, Aero-biology Monitoring Station, Trapani-Erice, Italy
 
Background
Modern agrobiology is the science that studies biological particles dispersed in the atmosphere, and, in our case, the pollens of allergizing plants. It is therefore involved in detecting the presence of pollens in the air, measuring their quantity, diagnosing and treating their effects. The diffusion of some allergizing plants is favoured by human activities. Of course, we are talking about vegetable species that are endemic in the area and typical of the climate, but their presence is favoured, though unawares, by man's activities and carelessness. Chenopodiaceae are herbaceous plants or shrubs, such as goosefoots or Chenopodium, growing also in ruderal and uncultivated places, but, mostly, in salty places, such as beaches and coast, along the saltwork basins or on seaweed sediments in decay. Moreover, in the last years, the presence of these plants where they had never grown before, such as dry areas and detritus heaps following the construction of breakwaters, piers and constructions built on the seaside that modified the coast ecosystem, has become more frequent. This is thought-provoking and confirms the importance of human activity on the changes in the territory and the relevant ecosystem.
Method
The aero-biologic monitoring was performed by ASMARA — Sicilian Association of Asthma.
Result
From the analysed data it has been observed that the pollen season for Chenopodiaceae, in Western Sicily, is in spring. Once the presence of the plants in the territory has been demonstrated, the real epidemiological impact on the allergic population was evaluated. This survey has been performed with allergic extracts produced by Lofarma S.p.A., Milan, Italy. The data collected showed a 14% of subjects allergic to Chenopodiaceae, and, among these, 10 were mono-sensitive.
Conclusion
In consideration of the discrepancy of the data published for macro-areas, it is essential for the agrobiology centres to diffuse the peculiar data of the local territory, reaching the largest possible number of interested subjects. Moreover, allergologists must know allergizing plants. In the last century, human activities deeply changed the territory, mostly in the urban coast areas. The plants of the Chenopodiaceae family have invaded these areas, growing luxuriantly near inhabited quarters. The plants of the Chenopodiaceae family induce a sensitization and a symptomatology that, if not correctly diagnosed, leads to a lack of efficacy of the therapeutic actions.

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THE SURVEY OF RHINITIS PHENOTYPES (SURF) STUDY GROUP

XXII World Allergy Congress - Cancun, Mexico, 4-8 December 2011
4002
SURVEY OF RHINITIS PHENOTYPES (SURF)
 
INTRODUCTION
Non-infectious rhinitis (NIR) is often considered a trivial disease, easily controlled by currently available symptomatic drugs. Recently, however, the attention of the scientific community and regulatory authorities has been drawn on the unmet needs of Severe Chronic Upper Airways Diseases  (SCUADs, Bousquet J et al., J Allergy Clin Immunol 2009;124:428-33), including NIR.
AIM
The Survey of Rhinitis Phenotypes (SURF) was an independent multicentre observational cross-sectional study promoted by the Italian Federation of Allergy and Clinical Immunology Societies (IFIACI) and the Italian Society for Pediatric Allergy and Immunology (SIAIP) to identify the phenotypes of NIR in both adults and children attending Italian Allergy Centers of excellence, as well to evaluate their dimension, clinical features and burden. Here are reported the results in adults.
METHODS
All IFIACI clinical centers fulfilling the Good Clinical Practice standards were invited to collect data by a standardized questionnaire from up to 50 consecutive patients over 18 years referred for of NIR in the period January 1 - June 30, 2011. Data management, entry and analysis was performed by a validated procedure in the respect of privacy requirements.
RESULTS
• 3383 patients referred for NIR with a duration of rhinitis symptoms of 7.0 ± 7.2 years entered the study, the 79.6% of whom suffered from allergic rhinitis (Fig. 1).
• Rhinitis was classifi ed as moderate/severe in the 40.5% of the patients with intermittent rhinitis and in the 68.7% of the patients with persistent rhinitis (Fig. 2).
• Allergic rhinitis - intermittent (20.2%) or persistent (79.8%) - was the most frequent clinical phenotype (79.6% of all forms of rhinitis). Allergic rhinitis was classifi ed as severe in 67.1% of intermittent forms and in 86.3% of persistent ones (Fig. 2).
• Grass (42.6%), Dermatophagoides pteronyssinus (32.2%) and Parietaria (23.9%) were the allergens most frequently responsible for a clinically relevant sensitization (Table 1).
• Co-morbidities: conjunctivitis (54%), asthma (38%), sinusitis (14%), sleep disturbances (8%) and nasal polyps (5%) were the co-morbidities most frequently associated with rhinitis (Fig. 3), particularly in the most severe forms, which in up to 46.3% of cases showed 2 or more co-morbid conditions.
• The undergoing treatment (anti-histamines in 77.1%, nasal steroids in 60.8%, anti-leukotrienes in 14.8% and oral steroids in 6.3% of cases) was considered unsatisfactory in 15.2% of cases by the doctor and in 29.0% by the patients (Fig. 4).
• Immunotherapy, although indicated in 73.8% of subjects with a clinically relevant sensitization and accepted by 56.3% of them (the high costs being the major cause for non-acceptance), was largely under-used in the patients studied.

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REGIRE - Registro Italiano Insufficienza Respiratoria
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Studio osservazionale

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Questo "Registro" ha avuto lo scopo di creare due Database per la raccolta e la registrazione dei dati relativi all’Insufficienza Respiratoria:

  •     Registro della VENTILAZIONE MECCANICA DOMICILIARE (VMD)

  •     Registro della OSSIGENOTERAPIA A LUNGO TERMINE (OLT)

Alla data del 15 aprile 2010 erano 102 i Centri Nazionali che hanno aderito all’iniziativa, consentendo di ribadire il valore del Registro che così ha colmato un vuoto scientifico rilevante.

Complessivamente, sono stati registrati i dati di circa 9.400 soggetti, di cui 7.100 nel Registro di Ossigenoterapia a Lungo Termine e 2.300 nel Registro dedicato alla Ventilazione Meccanica Domiciliare. I risultati del progetto sono stati oggetto di pubblicazioni nazionali ed internazionali che hanno incoraggiato ulteriori progetti ed investimenti rivolti all’ottimizzazione della prescrizione di OTLT e VDM.

È stato  pubblicato su Rassegna di Patologia dell’Apparato Respiratorio (N. 5/2015) l’articolo originale dal titolo “Registro Italiano Insufficienza Respiratoria: dati preliminari sull’Ossigenoterapia domiciliare (REGIRE-OLT)”.

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Lo Studio Osservazionale Trasversale REG.I.RE, ha avuto il seguente Timing:

  • dal 1° ottobre 2010 al 30 settembre 2011 => avvio del protocollo di studio e raccolta dei dati di prevalenza

  • dal 1° ottobre 2011 => raccolta dei dati per la valutazione dell’ incidenza su base annua (numero di nuovi casi per anno);

  • la variazione dell’incidenza su base annua è stata valutata per almeno 5 anni consecutivi.

  • lo studio si è concluso

I dati riportano che sul territorio nazionale la stragrande maggioranza dei pazienti affetti da BPCO presenta Insufficienza Respiratoria Cronica (IRC), patologia che determina uno stato di invalidità progressivamente ingravescente, limitando a lungo termine lo svolgimento di una normale vita di relazione. Inoltre, le implicazioni socio-economiche di questa sofferenza cronica sono enormi. Le previsioni per un prossimo futuro sono per un graduale incremento di incidenza legato principalmente a fattori quali: persistenza all’abitudine al fumo, innalzamento dell’età media, incremento del rischio di inquinamento ambientale, accresciuta incidenza di alcune patologie respiratorie.
Allo stato attuale pur disponendo di risorse terapeutiche (Ossigenoterapia a lungo termine, Ventiloterapia domiciliare), che se attuate in modo precoce possono controllare e/o ritardare l’evoluzione della IRC, non esiste tuttavia ancora un programma integrato di intervento sul territorio nazionale finalizzato ad assicurare un’efficace gestione dei vari livelli di gravità della patologia; inoltre non sono disponibili dati di incidenza e prevalenza sulla patologia.

L’obiettivo di REG.I.RE è stato quello di ottenere da un lato dati epidemiologici di prevalenza ed incidenza dell’Insufficienza Respiratoria, utili per una corretta programmazione sanitaria, e dall’altro di monitorare l’oculato impiego delle risorse per il trattamento della malattia, attraverso un moderno sistema informatico di gestione.


 Il Progetto REG.I.RE è realizzato grazie al contributo educazionale incondizionato di Boehringer Ingelheim  e  Pfizer

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