Registry for patients with severe asthma in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Structured physical activity program added to tezepelumab for adults with severe asthma

  A 12-week program to help adults with severe asthma who start tezepelumab see if adding guided physical activity improves activity levels and chances of remission.

  Recruiting University of Leeds · Leeds · NCT07735494

• Exercise program for adults with severe asthma starting biologics

  A tailored exercise program is being tested to see if it helps adults with severe asthma who are starting biologic therapy feel better and breathe better.

  Recruiting Helsinki University Central Hospital · Helsinki · NCT07655037

• Frevecitinib (KN-002) for severe asthma: a 12-week dose-ranging study

  This study tests three doses of frevecitinib vs placebo to see if it helps people with severe asthma not controlled by standard inhaled steroids and LABA therapy.

  Recruiting at 9 sites Phase 2 Kinaset Therapeutics Inc · Lancaster, California and 13 other locations · NCT07532265

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Tezepelumab to reduce maintenance medication in people with severe asthma

  This will test whether people aged 12–80 with severe asthma in China who start tezepelumab can safely reduce their regular maintenance medicines while keeping asthma controlled.

  Recruiting at 59 sites Phase 3 AstraZeneca · Beijing and 74 other locations · NCT07363642

• GB-0895 as an add-on treatment for severe uncontrolled asthma in adolescents and adults

  This test tries to see if adding GB-0895 every six months helps adolescents and adults whose severe asthma isn't controlled by inhaled steroids and other controllers.

  Recruiting at 158 sites Phase 3 Generate Biomedicines · Bakersfield, California and 157 other locations · NCT07359846

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.