Clinical Trials in Italy / NCT06625216
Recruiting
Observational
Severe Asthma Network Italy
NCT06625216 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Severe Asthma
Study 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
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.
Primary outcome measure(s)
- 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. - 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 clinical data: age, age at asthma onset and/or age at asthma diagnosis (years). - 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 clinical data: weight (kilograms) and height (meters) combined to report Body Mass Index \[BMI\] in kg/m\^2. - 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 clinical data: presence of allergies and/or comorbidities, previous accesses to ER and/or hospitalizations, and numbers of exacerbations. - 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. - 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 (percentages) 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 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 total serum IgE (kU/L). - 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 blood eosinophilia (10\^9 cells/L). - 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 blood and sputum eosinophil levels (percentages). - 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 \[ACQ\]. - 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 the quality of life through Asthma Quality of Life Questionnaire \[AQLQ\] . - 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy | Rozzano | Milano | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06625216 on ClinicalTrials.gov ↗ ← All trials in Italy