MANI Real-life Perspective Observatory

Societa Italiana di Pneumologia

Status: Enrolling

Conditions: Asthma; Mild Asthma; Moderate Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT04796844

MANI Project (Other Identifier)

456/2020 - DB id 10481

Details and patient eligibility

About

The purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.

Full description

To represent real-world mild moderate Italian asthmatics, all adults with diagnosed asthma by specialist, according GINA (Global Initiative for Asthma) document, 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 general practitioners will be delivered.

Subjects follow up will be scheduled according with GINA document and center plan (6 or 12 months follow up visit).

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients
• Asthma diagnosis according GINA 2020 algorithm (Annex 1)
• Patients enrolled in other previous or ongoing observational studies

Exclusion criteria

• Severe asthma patients according International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. [Chung KF et al. European Respiratory Journal Feb 2014, 43 (2) 343-373; DOI: 10.1183/09031936.00202013 (Annex 2)]
• Subjects are excluded from this cohort if they exhibit interstitial lung diseases, pulmonary neoplasms, current lung infections, immunological disorders leading to the use of immunosuppressants or continuous treatment with oral steroids.

Trial design