Severe Asthma Network Italy
Recruiting · NCT06625216 · Observational (researchers observe without assigning treatment) · Lead sponsor: Società Italiana di Allergologia, Asma e Immunologia Clinica
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Inclusion criteria
- signed informed consent and privacy disclaimer;
- age \> 12 years;
- diagnosis of severe asthma according to the ERS/ATS criteria:
- During treatment with:
- High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or
- Oral corticosteroids \>6 months/year
- 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.
Where it is running
1 location listed.
- Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy - Rozzano, Milano, Italy