NCT06625216Recruiting
Severe Asthma Network Italy
Observatory of Patients With Severe Asthma and Potential Eligible Patients for Treatment With Biological Drugs
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 5 Jul 2024
- Start date
- 17 Feb 2017
- Primary completion date
- 17 Feb 2027
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia Clinica
- Diseases
- Asthma
- NCT number
- NCT06625216
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 17 Feb 2017 to the primary completion date, 17 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Age in the registry: 13 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
Related publications
- Longitudinal observation of severe asthma comorbidities and oral corticosteroids use from SANI and ISAR registries.World Allergy Organ J · 2026 · PMID 41783626
This page is information, not medical advice. Discuss any trial with your doctor.