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Recruiting NCT06625216

Severe Asthma Network Italy

— Observational Severe Asthma

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Severe Asthma. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observatory of Patients With Severe Asthma and Potential Eligible Patients for Treatment With Biological Drugs

Overview

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. 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.

Primary outcome measures

  • Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: through study completion (the length of the follow up for each patient is scheduled for 10 years)]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, It — Rozzano

Publications

  • 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
  • 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: 10.1183/09031936.0020201 PMID 24337046
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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. PMID 23136642

Identifiers

NCT: NCT06625216 · ICH 1742

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗