Asthma
Conditions
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.
Interventions
None listed
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period. | 6-months period | Frequency of asthma treatments for asthma management, regardless the duration: * by active substance * by drug class * distinguishing between controller and reliever treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the clinical characteristics of subjects with mild asthma at enrolment visit | At enrolment | Lifestyle and smoking habits data description |
| To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit | At enrolment | Frequency of daytime and night-time symptoms |
| To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit | At enrolment | Time from first Asthma Diagnosis |
| To describe the asthma exacerbations of subjects with mild asthma at enrolment visit | At enrolment | Asthma exacerbations history data description |
| To describe the prior asthma treatment of subjects with mild asthma at enrolment visit | At enrolment | Type of prior Asthma treatments description |
| To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period | At enrolment and at 6-month | 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 |
| To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period | At enrolment and at 6-month | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FEV1 predicted value in %, |
| To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period | At enrolment and at 6-month | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): Forced Vital Capacity (FVC) in L |
| To describe the Socio-demographics data of subjects with mild asthma at enrolment visit | At enrolment | BMI in kg/m\^2 |
| To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period | At enrolment and at 6-month | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FEV1/FVC ratio in % |
| 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 | 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. |
| 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 | 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). |
| To describe the occurrence of asthma exacerbations during the 6-month observational period | 6-months 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) |
| To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period | 6-months period | Number of Inward/Day-hospital hospitalizations, emergency room accesses and GP/outpatient specialist visits |
| 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 | 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. |
| To describe the occurrence of adverse drug reactions (ADRs) in subjects with mild asthma during the 6-month observational period. | 6-month | Only Adverse Drug Reactions (ADRs) to any asthma medication occurred during the 6-month observational period will be collected |
| To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period | At enrolment and at 6-month | Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FVC % predicted |
Countries
Germany, Italy, Poland, Spain
Outcome results
None listed