Severe Asthma Network Italy

Recruiting

• Conditions: Severe Asthma

• Registration Number: NCT06625216
• Lead Sponsor: Società Italiana di Allergologia, Asma e Immunologia Clinica

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2024-07-05
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Primary Completion: 2027-02-17
• Study Completion: 2037-02-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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.	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.	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.	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.	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.

Trial Locations

Locations (1)

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy; 🇮🇹 Rozzano, Milano, Italy