Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2017-02-17
2037-02-17
Brief Summary
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The information recorded will provide:
1. The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.
2. The evaluation of adherence to treatment in real life.
3. The clinical eligibility of patients treated with biologics.
4. The evaluation of patients' clinical response to each treatment.
5. The monitoring of tolerability and safety.
6. The long-term follow up of patients with severe asthma.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. age \> 12 years;
3. diagnosis of severe asthma according to the ERS/ATS criteria:
1. During treatment with:
* High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or
* Oral corticosteroids \>6 months/year
2. at least one of the following occurs or would occur if treatment would be reduced:
* ACT \<20 or ACQ\>1.5
* At least 2 exacerbations in the last 12 months
* At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months
* FEV1 \<80% (if FEV1/FVC below the lower limit of normal)
13 Years
ALL
No
Sponsors
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Societa Italiana di Pneumologia
OTHER
Società Italiana di Allergologia, Asma e Immunologia Clinica
OTHER
Responsible Party
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Principal Investigators
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Enrico Marco Heffler, MD, PhD
Role: STUDY_CHAIR
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
Locations
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Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
Rozzano, Milano, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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/
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.
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.
Related Links
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Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, Revised 2014. Global Initiative for Asthma 2014
Other Identifiers
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ICH 1742
Identifier Type: -
Identifier Source: org_study_id
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