Study on Patterns of Care in Mild Asthmatic Patients (PRIME)

Chiesi

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT04598555

CLI-01535AA0-01

Details and patient eligibility

About

The PRIME study is an observational, Real World Evidence study designed to collect the type of treatments that are currently prescribed to patients with mild asthma and to collect relevant clinical data that could reflect the control of the disease over a 6-month observational period according to the standard clinical practice.

Full description

Outpatients attending the hospital clinics/study centres will be recruited. Patients with mild asthma treated by Step 1 or step 2 treatments according to GINA report will be recruited. A total of approximately 1200 patients will be enrolled. Patients will be followed-up during a 6-month observational period according to standard practices.

Enrollment: 981 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subject (aged ≥ 18 years) up to 75 years
• Subject with confirmed asthma diagnosis
• Subject in treatment for mild asthma with Step 1 or Step 2 according to GINA report
• Subject with written privacy and study informed consent

Exclusion criteria

• Subject enrolled in experimental (interventional) clinical trials, or receiving experimental treatments in the prior 3 months
• Known pregnant or breast-feeding subject
• Subject unable to understand and autonomously fill in questionnaires
• Subject unable to use electronic devices to fill in e-diary, or without compatible electronic devices with access to the Internet
• Subject who had asthma exacerbation(s) in the past 4 weeks prior to study entry
• Subject with confirmed Chronic Obstructive Pulmonary Disease