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| Name | Class |
|---|---|
| Societa Italiana di Pneumologia | OTHER |
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The goal of this registry is collecting data of severe asthma patients, recruited by specialized centers, in a real life setting, homogeneously placed on a database management system to follow them over the time.
The information recorded will provide:
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| Measure | Description | Time Frame |
|---|---|---|
| Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry. | Collection of sociodemographic data: sex, employment, ethnicity, smocking habits. | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry. | Collection of clinical data: age, age at asthma onset and/or age at asthma diagnosis (years). | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry. | Collection of clinical data: weight (kilograms) and height (meters) combined to report Body Mass Index [BMI] in kg/m^2. | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry. | Collection of clinical data: presence of allergies and/or comorbidities, previous accesses to ER and/or hospitalizations, and numbers of exacerbations. | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Collecting functional data of severe asthmatics from SANI registry. | Assessment of lung function before and after a bronchodilator medication: Forced Vital Capacity [FVC] and Forced Expiratory Volume in 1 second [FEV1] values (liters) combined to report FEV1/FVC Ratio. | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
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Inclusion Criteria:
signed informed consent and privacy disclaimer;
age > 12 years;
diagnosis of severe asthma according to the ERS/ATS criteria:
During treatment with:
at least one of the following occurs or would occur if treatment would be reduced:
Exclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.
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Patients older than 12 years, diagnosed for severe asthma by a specialist, according to the ERS/ATS criteria, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. If inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her GPs will be delivered.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrico Marco Heffler, MD, PhD | Contact | 0282241 | +39 | enrico.heffler@hunimed.eu |
| Concetta Sirena | Contact | 3420790871 | +39 | concetta.sirena@infomed-online.it |
| Name | Affiliation | Role |
|---|---|---|
| Enrico Marco Heffler, MD, PhD | Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy | Recruiting | Rozzano | Milano | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22251060 | Background | Wenzel S. Severe asthma: from characteristics to phenotypes to endotypes. Clin Exp Allergy. 2012 May;42(5):650-8. doi: 10.1111/j.1365-2222.2011.03929.x. Epub 2012 Jan 18. | |
| 24337046 | Background | Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12. |
| Label | URL |
|---|---|
| Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, Revised 2014. Global Initiative for Asthma 2014 | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Serum and induced sputum samples
| Collecting functional data of severe asthmatics from SANI registry. |
Assessment of lung function before and after a bronchodilator medication: Forced Vital Capacity [FVC] and Forced Expiratory Volume in 1 second [FEV1] values (percentages) combined to report FEV1/FVC Ratio. |
| through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Assessing inflammatory markers in order to characterize asthma endotypes. | Measurement of Fractional exhaled Nitric Oxide [FeNO] (ppb). | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Assessing inflammatory markers in order to characterize asthma endotypes. | Measurement of total serum IgE (kU/L). | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Assessing inflammatory markers in order to characterize asthma endotypes. | Measurement of blood eosinophilia (10^9 cells/L). | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Assessing inflammatory markers in order to characterize asthma endotypes. | Measurement of blood and sputum eosinophil levels (percentages). | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Assessing asthma control and and PROs. | Assessment of asthma control over time according to the GINA Guidelines and standardized questionnaires: Asthma Control Test [ACT], and Asthma Control Questionnaire [ACQ]. | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Assessing asthma control and and PROs. | Assessment of the quality of life through Asthma Quality of Life Questionnaire [AQLQ] . | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| Studying the real life efficacy and safety of biologics. | Evaluation of patients' clinical response to each biologics, reports of previous adverse reactions to the drug used and reasons for withdrawal from biologic treatment. | through study completion (the length of the follow up for each patient is scheduled for 10 years) |
| 26566089 | Background | De Ferrari L, Chiappori A, Bagnasco D, Riccio AM, Passalacqua G, Canonica GW. Molecular phenotyping and biomarker development: are we on our way towards targeted therapy for severe asthma? Expert Rev Respir Med. 2016;10(1):29-38. doi: 10.1586/17476348.2016.1111763. Epub 2015 Nov 13. |
| 26883543 | Background | Latorre M, Baldini C, Seccia V, Pepe P, Novelli F, Celi A, Bacci E, Cianchetti S, Dente FL, Bombardieri S, Paggiaro P. Asthma Control and Airway Inflammation in Patients with Eosinophilic Granulomatosis with Polyangiitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):512-9. doi: 10.1016/j.jaip.2015.12.014. Epub 2016 Feb 13. |
| 26383000 | Background | Chung KF. Targeting the interleukin pathway in the treatment of asthma. Lancet. 2015 Sep 12;386(9998):1086-96. doi: 10.1016/S0140-6736(15)00157-9. |
| 23197041 | Background | Pelaia G, Vatrella A, Maselli R. The potential of biologics for the treatment of asthma. Nat Rev Drug Discov. 2012 Dec;11(12):958-72. doi: 10.1038/nrd3792. |
| 27399975 | Background | Bagnasco D, Ferrando M, Bernardi S, Passalacqua G, Canonica GW. The path to personalized medicine in asthma. Expert Rev Respir Med. 2016 Sep;10(9):957-65. doi: 10.1080/17476348.2016.1205490. Epub 2016 Jul 11. |
| 23136642 | Background | Chipps BE, Zeiger RS, Dorenbaum A, Borish L, Wenzel SE, Miller DP, Hayden ML, Bleecker ER, Simons FE, Szefler SJ, Weiss ST, Haselkorn T; TENOR Study Group. Assessment of asthma control and asthma exacerbations in the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) observational cohort. Curr Respir Care Rep. 2012 Dec;1(4):259-269. doi: 10.1007/s13665-012-0025-x. Epub 2012 Sep 20. |
| 22694932 | Background | Chipps BE, Zeiger RS, Borish L, Wenzel SE, Yegin A, Hayden ML, Miller DP, Bleecker ER, Simons FE, Szefler SJ, Weiss ST, Haselkorn T; TENOR Study Group. Key findings and clinical implications from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin Immunol. 2012 Aug;130(2):332-42.e10. doi: 10.1016/j.jaci.2012.04.014. Epub 2012 Jun 12. |
| 25456708 | Background | Schleich F, Brusselle G, Louis R, Vandenplas O, Michils A, Pilette C, Peche R, Manise M, Joos G. Heterogeneity of phenotypes in severe asthmatics. The Belgian Severe Asthma Registry (BSAR). Respir Med. 2014 Dec;108(12):1723-32. doi: 10.1016/j.rmed.2014.10.007. Epub 2014 Oct 27. |
| 3350994 | Background | Ferry JJ, Horvath AM, Bekersky I, Heath EC, Ryan CF, Colburn WA. Relative and absolute bioavailability of prednisone and prednisolone after separate oral and intravenous doses. J Clin Pharmacol. 1988 Jan;28(1):81-7. doi: 10.1002/j.1552-4604.1988.tb03105.x. |
| 24414989 | Background | Normansell R, Walker S, Milan SJ, Walters EH, Nair P. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev. 2014 Jan 13;2014(1):CD003559. doi: 10.1002/14651858.CD003559.pub4. |
| 25281265 | Background | Novelli F, Latorre M, Vergura L, Caiaffa MF, Camiciottoli G, Guarnieri G, Matucci A, Macchia L, Vianello A, Vultaggio A, Celi A, Cazzola M, Paggiaro P; Xolair Italian Study Group. Asthma control in severe asthmatics under treatment with omalizumab: a cross-sectional observational study in Italy. Pulm Pharmacol Ther. 2015 Apr;31:123-9. doi: 10.1016/j.pupt.2014.09.007. Epub 2014 Sep 30. |
| 25640019 | Background | Caminati M, Senna G, Guerriero M, Dama AR, Chieco-Bianchi F, Stefanizzi G, Montagni M, Ridolo E. Omalizumab for severe allergic asthma in clinical trials and real-life studies: what we know and what we should address. Pulm Pharmacol Ther. 2015 Apr;31:28-35. doi: 10.1016/j.pupt.2015.01.006. Epub 2015 Jan 30. |
| 15672843 | Background | Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026. |
| 23721684 | Background | Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, Bruce J. The eXpeRience registry: the 'real-world' effectiveness of omalizumab in allergic asthma. Respir Med. 2013 Aug;107(8):1141-51. doi: 10.1016/j.rmed.2013.04.017. Epub 2013 May 28. |
| 20688929 | Background | Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest. 2011 Jan;139(1):28-35. doi: 10.1378/chest.10-1194. Epub 2010 Aug 5. |
| 25834884 | Background | Omalizumab Treatment for Adults and Children with Allergic Asthma: A Review of the Clinical Effectiveness, Cost-Effectiveness, and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Mar 9. Available from http://www.ncbi.nlm.nih.gov/books/NBK280029/ |
| 41783626 | Derived | Guida G, Scelo G, Friston DA, Blasi F, Heffler E, Paggiaro P, Carter V, Caminati M, Ricciardolo FLM, Senna G, Price DB, Canonica GW; SANI network. Longitudinal observation of severe asthma comorbidities and oral corticosteroids use from SANI and ISAR registries. World Allergy Organ J. 2026 Feb 26;19(3):101345. doi: 10.1016/j.waojou.2026.101345. eCollection 2026 Mar. |
| 40458738 | Derived | Ridolo E, Ottoni M, Nicoletta F, Locatelli F, Martinelli L, Maule M, Cheema NA, Blasi F, Paggiaro P, Heffler E, Brussino L, Canonica GW, Senna G, Caminati M; SANI network. Role of body anthropometry in severe asthmatic patients: Evidences from the Severe Asthma Network in Italy (SANI) registry. World Allergy Organ J. 2025 May 5;18(5):101056. doi: 10.1016/j.waojou.2025.101056. eCollection 2025 May. |
| 39829953 | Derived | Canonica GW, Blasi F, Paggiaro P, Heffler E, Braido F, Brussino L, Scioscia G, Cardini C, Oriecuia C, Sala I, Bagnardi V; SANI (Severe Asthma Network in Italy) study group. Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI). World Allergy Organ J. 2024 Dec 27;18(1):101016. doi: 10.1016/j.waojou.2024.101016. eCollection 2025 Jan. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |