Severe Asthma Network Italy (SANI)

Società Italiana di Allergologia, Asma e Immunologia Clinica

Status: Enrolling

Conditions: Severe Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT06625216

ICH 1742

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.