| NCT ID | NCT06625216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Società Italiana di Allergologia, Asma e Immunologia Clinica |
| Condition | Severe Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2017-02-17 |
| Primary Completion | 2027-02-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2017-02-17 with a primary completion date of 2027-02-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Enrico Marco Heffler, MD, PhD
STUDY CHAIR
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
Frequently Asked Questions
Who can join the NCT06625216 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Severe Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06625216 currently recruiting?
Yes, NCT06625216 is actively recruiting participants. Contact the research team at enrico.heffler@hunimed.eu for enrollment information.
Where is the NCT06625216 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT06625216 clinical trial?
NCT06625216 is sponsored by Società Italiana di Allergologia, Asma e Immunologia Clinica. The principal investigator is Enrico Marco Heffler, MD, PhD at Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy. The trial plans to enroll 5,000 participants.
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