Study on Patterns of Care in Mild Asthmatic Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period. | Frequency of asthma treatments for asthma management, regardless the duration: by active substance by drug class distinguishing between controller and reliever treatments | 6-months period | 
| To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period. | Frequency of subjects experiencing asthma treatment switches, step-ups and step-downs during the observation period, along with the description of pattern of switch (in terms of sequence of treatments over time) | 6-months period | 
| To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period. | Frequency of treatment posology, stratified by type of asthma treatment | 6-months period | 
| To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational 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. | 6-months period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the Socio-demographics data of subjects with mild asthma at enrolment visit | BMI in kg/m^2 | At enrolment | 
| To describe the clinical characteristics of subjects with mild asthma at enrolment visit | Lifestyle and smoking habits data description | At enrolment | 
| To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit | Frequency of daytime and night-time symptoms | At enrolment | 
| To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit | Type of daytime and night-time symptoms | At enrolment | 
| To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit | Time from first Asthma Diagnosis | At enrolment | 
| To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit | Type of diagnosis strategy | At enrolment | 
| To describe the asthma exacerbations of subjects with mild asthma at enrolment visit | Asthma exacerbations history data description | At enrolment | 
| To describe the prior asthma treatment of subjects with mild asthma at enrolment visit | Type of prior Asthma treatments description | At enrolment | 
| To describe the clinical characteristics of subjects with mild asthma at enrolment visit | Skin Prick test data description | At enrolment | 
| To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of Forced Expiratory Volume in 1 second (FEV1) in L | At enrolment and at 6-month | 
| To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FEV1 predicted value in %, | At enrolment and at 6-month | 
| To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): Forced Vital Capacity (FVC) in L | At enrolment and at 6-month | 
| To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FVC % predicted | At enrolment and at 6-month | 
| To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FEV1/FVC ratio in % | At enrolment and at 6-month | 
| To describe subjects' level of asthma symptoms control by means of the Asthma Control Test (ACT) during the 6-month observational period | ACT score. ACT is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). ACT scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | At enrolment and at 6-month | 
| To describe subjects' level of asthma symptoms control by means of the Asthma Control Questionnaire (ACQ-5) during the 6-month observational period | ACQ-5 score. ACQ-5 is a 7-point scale (0=no impairment, 6= maximum impairment) and scores range between 0 (totally controlled) and 6 (severely uncontrolled). | At enrolment and at 6-month | 
| To describe the occurrence of asthma exacerbations during the 6-month observational period | Number of Asthma exacerbations during the 6-month observational period (seriousness, severity, relatedness to the treatment product, start date and end date (duration will be calculated during data analysis), outcome, action taken with respect to drug and other treatments used to treat exacerbations) | 6-months period | 
| To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period | Number of Inward/Day-hospital hospitalizations, emergency room accesses and GP/outpatient specialist visits | 6-months period | 
| To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period | Number and type of tests and exams per subject | 6-months period | 
| To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period | Duration of Inward/Day-hospital hospitalizations | 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 | MiniAQLQ scores. The MiniAQLQ is a 7-point Likert scale (7 = not impaired at all - 1 = severely impaired) and scores range 1-7, with higher scores indicating better quality of life. | 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. | Only Adverse Drug Reactions (ADRs) to any asthma medication occurred during the 6-month observational period will be collected | 6-month |