Severe AsthmaSANINCT06625216
Severe Asthma Network Italy
An observational study of Severe Asthma, run by Società Italiana di Allergologia, Asma e Immunologia Clinica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2017to 17 Feb 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
Rozzano, Milano, 20089
Enrico Marco Heffler, MD, PhD, 0282241, enrico.heffler@hunimed.eu
About this study
Official title: Observatory of Patients With Severe Asthma and Potential Eligible Patients for Treatment With Biological Drugs
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:
- The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.
- The evaluation of adherence to treatment in real life.
- The clinical eligibility of patients treated with biologics.
- The evaluation of patients' clinical response to each treatment.
- The monitoring of tolerability and safety.
- The long-term follow up of patients with severe asthma.
- Conditions
- Severe Asthma
- Keywords
- Severe Asthma, Network, Registry, Biologics, Adherence
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
Collection of sociodemographic data: sex, employment, ethnicity, smocking habits.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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].
Measured: 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] .
Measured: 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.
Measured: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start17 Feb 2017
- Primary completion17 Feb 2027 (estimated)
- Study completion17 Feb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia Clinica
- Sponsor type
- University, hospital or other
- Collaborators
- Societa Italiana di Pneumologia
- Responsible party
- Sponsor
- Investigators
- Enrico Marco Heffler, MD, PhD, Study chair, Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625216
- Sponsor's protocol ID
- ICH 1742
- Acronym
- SANI
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22251060Chung 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.
PubMed 24337046De 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.
PubMed 26566089Latorre 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.
PubMed 26883543Chung 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.
PubMed 26383000Pelaia 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.
PubMed 23197041Bagnasco 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.
PubMed 27399975Chipps 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.
PubMed 23136642Chipps 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.
PubMed 22694932Schleich 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.
PubMed 25456708Ferry 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.
PubMed 3350994Normansell 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.
PubMed 24414989Novelli 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.
PubMed 25281265Caminati 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.
PubMed 25640019Herland 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.
PubMed 15672843
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Patients With Severe Asthma and Potential Eligible Patients for Treatment With Biological Drugs
- ClinicalTrials.gov ID
- NCT06625216
- Acronym / sponsor ID
- SANI / ICH 1742
- Conditions
- Severe Asthma
- Keywords
- Severe Asthma, Network, Registry, Biologics, Adherence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia ClinicaUniversity, hospital or other
- Collaborators
- Societa Italiana di Pneumologia
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 17 Feb 2037 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.
- The evaluation of adherence to treatment in real life.
- The clinical eligibility of patients treated with biologics.
- The evaluation of patients' clinical response to each treatment.
- The monitoring of tolerability and safety.
- The long-term follow up of patients with severe asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- signed informed consent and privacy disclaimer;
- age > 12 years;
- diagnosis of severe asthma according to the ERS/ATS criteria:
- Exclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Collection of sociodemographic data: sex, employment, ethnicity, smocking habits.
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)
Collection of clinical data: age, age at asthma onset and/or age at asthma diagnosis (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)
Collection of clinical data: weight (kilograms) and height (meters) combined to report Body Mass Index [BMI] in kg/m^2.
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)
Collection of clinical data: presence of allergies and/or comorbidities, previous accesses to ER and/or hospitalizations, and numbers of exacerbations.
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)
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.
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)
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.
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)
Measurement of Fractional exhaled Nitric Oxide [FeNO] (ppb).
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)
Measurement of total serum IgE (kU/L).
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)
Measurement of blood eosinophilia (10^9 cells/L).
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)
Measurement of blood and sputum eosinophil levels (percentages).
Assessing asthma control and and PROs.
Time frame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Assessment of asthma control over time according to the GINA Guidelines and standardized questionnaires: Asthma Control Test [ACT], and Asthma Control Questionnaire [ACQ].
Assessing asthma control and and PROs.
Time frame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Assessment of the quality of life through Asthma Quality of Life Questionnaire [AQLQ] .
Studying the real life efficacy and safety of biologics.
Time frame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Evaluation of patients' clinical response to each biologics, reports of previous adverse reactions to the drug used and reasons for withdrawal from biologic treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 22251060Wenzel 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.
- Background: PubMed 24337046Chung 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.
- Background: PubMed 26566089De 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.
- Background: PubMed 26883543Latorre 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.
- Background: PubMed 26383000Chung 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.
- Background: PubMed 23197041Pelaia 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.
- Background: PubMed 27399975Bagnasco 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.
- Background: PubMed 23136642Chipps 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.
- Background: PubMed 22694932Chipps 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.
- Background: PubMed 25456708Schleich 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.
- Background: PubMed 3350994Ferry 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.
- Background: PubMed 24414989Normansell 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.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, Revised 2014. Global Initiative for Asthma 2014Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Marco Heffler, MD, PhD study chair
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Società Italiana di Allergologia, Asma e Immunologia Clinica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Marco Heffler, MD, PhD (0282241 ext. +39, enrico.heffler@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06625216, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.