Observatory of Patients with Severe Asthma and Potential Eligible Patients for Treatment with Biological Drugs

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:

• 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
Other Locations
Italy
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
RECRUITING
Rozzano
Contact Information
Primary
Enrico Marco Heffler, MD, PhD
enrico.heffler@hunimed.eu
0282241
Backup
Concetta Sirena
concetta.sirena@infomed-online.it
3420790871
Time Frame
Start Date: 2017-02-17
Estimated Completion Date: 2037-02-17
Participants
Target number of participants: 5000
Related Therapeutic Areas
Sponsors
Collaborators: Societa Italiana di Pneumologia
Leads: Società Italiana di Allergologia, Asma e Immunologia Clinica

This content was sourced from clinicaltrials.gov