Severe Asthma Network Italy
Observatory of Patients with Severe Asthma and Potential Eligible Patients for Treatment with Biological Drugs
Società Italiana di Allergologia, Asma e Immunologia Clinica
5,000 participants
Feb 17, 2017
OBSERVATIONAL
Conditions
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
Inclusion Criteria11
- 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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06625216