Severe Asthma Network Italy (SANI)

April 23, 2026 updated by: Società Italiana di Allergologia, Asma e Immunologia Clinica

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:

  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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. signed informed consent and privacy disclaimer;
  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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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.
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)
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.
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.
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)
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.
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).
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)
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.
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).
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)
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.
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].
through study completion (the length of the follow up for each patient is scheduled for 10 years)
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] .
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.
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.
through study completion (the length of the follow up for each patient is scheduled for 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Società Italiana di Allergologia, Asma e Immunologia Clinica

Collaborators

Societa Italiana di Pneumologia

Investigators

  • Study Chair: Enrico Marco Heffler, MD, PhD, Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Estimated)

February 17, 2027

Study Completion (Estimated)

February 17, 2037

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICH 1742

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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