Recruiting

Severe Asthma Network Italy

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…

ClinicalTrials.gov IDNCT06625216

PhaseNot Applicable

Enrollment5000

SponsorSocietà Italiana di Allergologia, Asma e Immunologia Clinica

Age13 Years

SexALL

I'm interested View official listing

Conditions studied

Severe Asthma

About this study

Primary outcomes

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

Eligibility information

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 locations

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy, Rozzano, Milano 20089 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.