Registry for patients with severe asthma in Italy
Observatory of Patients With Severe Asthma and Potential Eligible Patients for Treatment With Biological Drugs
This study is collecting information from people with severe asthma in Italy to see how well their treatments are working and to improve care for them over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Società Italiana di Allergologia, Asma e Immunologia Clinica Academic / other |
| Locations | 1 site (Rozzano, Milano) |
| Trial ID | NCT06625216 on ClinicalTrials.gov |
What this trial studies
This registry collects data from patients with severe asthma recruited by specialized centers in Italy, aiming to create a comprehensive database for long-term follow-up. It focuses on gathering clinical, functional, and biological data to evaluate treatment adherence and clinical responses to biologics. The study also monitors the safety and tolerability of treatments in a real-life setting, providing valuable insights into the management of severe asthma. By tracking these patients over time, the registry seeks to enhance understanding and improve care for individuals with this condition.
Who should consider this trial
Good fit: Ideal candidates for this registry are individuals aged over 12 years with a diagnosis of severe asthma who meet specific treatment criteria.
Not a fit: Patients with mild or moderate asthma may not receive any benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment strategies and better management of severe asthma for patients.
How similar studies have performed: Other similar registries have shown success in improving understanding and management of chronic conditions, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rozzano, Milano
- Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy — Rozzano, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Enrico Marco Heffler, MD, PhD
- Email: enrico.heffler@hunimed.eu
- Phone: 0282241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.