Severe Asthma
Conditions
Keywords
Severe Asthma, Network, Registry, Biologics, Adherence
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.
Interventions
None listed
Sponsors
Società Italiana di Allergologia, Asma e Immunologia Clinica
Societa Italiana di Pneumologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry. | through study completion (the length of the follow up for each patient is scheduled for 10 years) | Collection of sociodemographic data: sex, employment, ethnicity, smocking habits. |
| Collecting functional data of severe asthmatics from SANI registry. | through study completion (the length of the follow up for each patient is scheduled for 10 years) | Assessment of lung function before and after a bronchodilator medication: Forced Vital Capacity \[FVC\] and Forced Expiratory Volume in 1 second \[FEV1\] values (liters) combined to report FEV1/FVC Ratio. |
| Assessing inflammatory markers in order to characterize asthma endotypes. | through study completion (the length of the follow up for each patient is scheduled for 10 years) | Measurement of Fractional exhaled Nitric Oxide \[FeNO\] (ppb). |
| Assessing asthma control and and PROs. | through study completion (the length of the follow up for each patient is scheduled for 10 years) | Assessment of asthma control over time according to the GINA Guidelines and standardized questionnaires: Asthma Control Test \[ACT\], and Asthma Control Questionnaire \[ACQ\]. |
| Studying the real life efficacy and safety of biologics. | through study completion (the length of the follow up for each patient is scheduled for 10 years) | Evaluation of patients' clinical response to each biologics, reports of previous adverse reactions to the drug used and reasons for withdrawal from biologic treatment. |
Countries
Italy
Contacts
CONTACTEnrico Marco Heffler, MD, PhD
CONTACTConcetta Sirena
STUDY_CHAIREnrico Marco Heffler, MD, PhD
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
Outcome results
None listed