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NCT Number: NCT06625216

Severe Asthma Network Italy

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.

Recruiting

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

Rozzano, Milano, 20089, Italy

Location status: Recruiting

Location contact

Enrico Marco Heffler, MD, PhD

CONTACT

[email protected]

0282241

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

have not been considered in order to have a realistic view of severe asthma in real life.

Treatment and study plan

Primary outcomes

  1. Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.

    Time frame: 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.

  2. Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.

    Time frame: 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).

  3. Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.

    Time frame: 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.

  4. Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.

    Time frame: 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.

  5. Collecting functional data of severe asthmatics from SANI registry.

    Time frame: 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.

  6. Collecting functional data of severe asthmatics from SANI registry.

    Time frame: 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.

  7. Assessing inflammatory markers in order to characterize asthma endotypes.

    Time frame: 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).

  8. Assessing inflammatory markers in order to characterize asthma endotypes.

    Time frame: through study completion (the length of the follow up for each patient is scheduled for 10 years)

    Measurement of total serum IgE (kU/L).

  9. Assessing inflammatory markers in order to characterize asthma endotypes.

    Time frame: 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).

  10. Assessing inflammatory markers in order to characterize asthma endotypes.

    Time frame: 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).

  11. Assessing asthma control and and PROs.

    Time frame: 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].

  12. Assessing asthma control and and PROs.

    Time frame: 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] .

  13. Studying the real life efficacy and safety of biologics.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Concetta Sirena

CONTACT

[email protected]

3420790871 ext. +39

Enrico Marco Heffler, MD, PhD

CONTACT

[email protected]

0282241 ext. +39

Sponsors and collaborators

Lead sponsor

Società Italiana di Allergologia, Asma e Immunologia Clinica

Other

Collaborators

  • Societa Italiana di Pneumologia

Registry information

Official study title

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

Acronym: SANI

Important dates

Study start
2017
Primary completion
2027
Study completion
2037
First posted
Oct 3, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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