A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts

Chiesi Farmaceutici S.p.A.59 sites in 4 countries981 target enrollmentFebruary 25, 2021

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 981
Locations: 59
Primary Endpoint: To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

February 25, 2021

End Date

September 2, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Chiesi Farmaceutici S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.

Time Frame: 6-months period

Duration of asthma treatments (in months): * overall * by drug class (i.e., any switch to drugs within the same class will be considered as a continuation of the treatment) and by active substance (i.e., any dose adaptation will be considered as a continuation of the same drug). This will be adapted according to data availability.

Secondary Outcomes

To describe the prior asthma treatment of subjects with mild asthma at enrolment visit(At enrolment)
To describe the clinical characteristics of subjects with mild asthma at enrolment visit(At enrolment)
To describe the asthma exacerbations of subjects with mild asthma at enrolment visit(At enrolment)
To describe subjects' level of asthma symptoms control by means of the Asthma Control Questionnaire (ACQ-5) during the 6-month observational period(At enrolment and at 6-month)
To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period(At enrolment and at 6-month)
To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period(At enrolment and at 6-month)
To describe the occurrence of asthma exacerbations during the 6-month observational period(6-months period)
To describe the subjects' quality of life by means of the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) during the 6-month observational period(At enrolment and at 6-month)
To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit(At enrolment)
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit(At enrolment)
To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period(At enrolment and at 6-month)
To describe the occurrence of adverse drug reactions (ADRs) in subjects with mild asthma during the 6-month observational period.(6-month)
To describe the Socio-demographics data of subjects with mild asthma at enrolment visit(At enrolment)
To describe subjects' level of asthma symptoms control by means of the Asthma Control Test (ACT) during the 6-month observational period(At enrolment and at 6-month)
To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period(6-months period)
To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period(At enrolment and at 6-month)
To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period(At enrolment and at 6-month)