Severe Asthma Network Italy
ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorSocietà Italiana di Allergologia, Asma e Immunologia Clinica
About this trial
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
This trial does not accept healthy volunteersQualifiers
signed informed consent and privacy disclaimer;
age > 12 years;
High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or
Oral corticosteroids >6 months/year
Disqualifiers
None
Trial population
Patients older than 12 years, diagnosed for severe asthma by a specialist, according to the ERS/ATS criteria, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. If inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her GPs will be delivered.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
Collection of sociodemographic data: sex, employment, ethnicity, smocking habits.
Time frame
through study completion (the length of the follow up for each patient is scheduled for 10 years)2
Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
Collection of clinical data: age, age at asthma onset and/or age at asthma diagnosis (years).
Time frame
through study completion (the length of the follow up for each patient is scheduled for 10 years)3
Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
Collection of clinical data: weight (kilograms) and height (meters) combined to report Body Mass Index \[BMI\] in kg/m\^2.
Time frame
through study completion (the length of the follow up for each patient is scheduled for 10 years)4
Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
Collection of clinical data: presence of allergies and/or comorbidities, previous accesses to ER and/or hospitalizations, and numbers of exacerbations.
Time frame
through study completion (the length of the follow up for each patient is scheduled for 10 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Società Italiana di Allergologia, Asma e Immunologia Clinica
Lead sponsor
Societa Italiana di Pneumologia
Collaborator
Source ClinicalTrials.gov