Clinical trial NCT06625216: Severe Asthma Network Italy
Official title: Observatory of Patients with Severe Asthma and Potential Eligible Patients for Treatment with Biological Drugs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Asthma
Keywords: Severe Asthma
Network
Registry
Biologics
Adherence
Lead sponsor: Società Italiana di Allergologia, Asma e Immunologia Clinica
Sponsor class: OTHER
Collaborators: name: Societa Italiana di Pneumologia
First posted: 2024-10-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Collecting functional data of severe asthmatics from SANI registry.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Collecting functional data of severe asthmatics from SANI registry.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Assessing inflammatory markers in order to characterize asthma endotypes.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Assessing inflammatory markers in order to characterize asthma endotypes.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Assessing inflammatory markers in order to characterize asthma endotypes.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Assessing inflammatory markers in order to characterize asthma endotypes.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Assessing asthma control and and PROs.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Assessing asthma control and and PROs.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
measure: Studying the real life efficacy and safety of biologics.
timeFrame: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
state: Milano
Study officials:
affiliation: Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
name: Enrico Marco Heffler, MD, PhD
role: STUDY_CHAIR
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