Severe Asthma Network Italy

NCT06625216 | Recruiting

• 1 other identifier: ICH 1742
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.
2. 2.The evaluation of adherence to treatment in real life.
3. 3.The clinical eligibility of patients treated with biologics.
4. 4.The evaluation of patients' clinical response to each treatment.
5. 5.The monitoring of tolerability and safety.
6. 6.The long-term follow up of patients with severe asthma.

Conditions

Severe Asthma

Keywords

Severe Asthma; Network; Registry; Biologics; Adherence

Outcome Measures

Primary Outcomes (13)

• 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)

• 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)

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• signed informed consent and privacy disclaimer;
• age \> 12 years;
• diagnosis of severe asthma according to the ERS/ATS criteria:
• During treatment with:
• High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or
• Oral corticosteroids \>6 months/year
• 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)

Sponsors & Collaborators

• Società Italiana di Allergologia, Asma e Immunologia Clinica: lead
• Societa Italiana di Pneumologia: collaborator

Study Sites (1)

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

Rozzano, Milano, 20089, Italy

RECRUITING

Related Publications (21)

• 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.

  PMID: 22251060 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.

  PMID: 24337046 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.

  PMID: 26566089 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.

  PMID: 26883543 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.

  PMID: 26383000 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.

  PMID: 23197041 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.

  PMID: 27399975 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.

  PMID: 23136642 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.

  PMID: 22694932 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.

  PMID: 25456708 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.

  PMID: 3350994 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.

  PMID: 24414989 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.

  PMID: 25281265 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.

  PMID: 25640019 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.

  PMID: 15672843 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.

  PMID: 23721684 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.

  PMID: 20688929 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/

  PMID: 25834884 BACKGROUND

• 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.

  PMID: 41783626 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.

  PMID: 40458738 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.

  PMID: 39829953 DERIVED

Related Links

• Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, Revised 2014. Global Initiative for Asthma 2014

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and induced sputum samples

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Enrico Marco Heffler, MD, PhD

  Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

  STUDY CHAIR

Central Study Contacts

Enrico Marco Heffler, MD, PhD

CONTACT

0282241; enrico.heffler@hunimed.eu

Concetta Sirena

CONTACT

3420790871; concetta.sirena@infomed-online.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: October 3, 2024
• Study Start: February 17, 2017
• Primary Completion (Estimated): February 17, 2027
• Study Completion (Estimated): February 17, 2037
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

IT (1)