Study on Patterns of Care in Mild Asthmatic Patients
- Conditions
- Asthma
- Registration Number
- NCT04598555
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 981
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period. 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 Outcome Measures
Name Time Method 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
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 clinical characteristics of subjects with mild asthma at enrolment visit At enrolment Skin Prick test data description
To describe the asthma exacerbations of subjects with mild asthma at enrolment visit At enrolment Asthma exacerbations history data description
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 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 (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 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 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 Daytime and night-time symptoms of subjects with mild asthma at enrolment visit At enrolment Type of daytime and night-time symptoms
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit At enrolment Type of diagnosis strategy
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 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 Socio-demographics data of subjects with mild asthma at enrolment visit At enrolment BMI in kg/m\^2
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 the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period 6-months period Duration of Inward/Day-hospital hospitalizations
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 %,
Trial Locations
- Locations (59)
DE-008 Lungenarztpraxis Hellersdorf
🇩🇪Berlin, Germany
DE-003 Praxis Pneumologie und Allergologie Dr. Ginko
🇩🇪Bonn, Germany
DE-005 Praxis für Pneumologie und Innere Medizin
🇩🇪Fürstenwalde, Germany
DE-006 Studieninstitut des Pneumologicums Halle
🇩🇪Halle, Germany
DE-001 Salvus - Klinische Studien GmbH
🇩🇪Leipzig, Germany
DE-007 POIS Leipzig GbR
🇩🇪Leipzig, Germany
DE-004 Fortbildungs- und Studienzentrum Innere Medizin Marburg GbR
🇩🇪Marburg, Germany
DE-009 Praxis Dr. Jansen
🇩🇪Menden, Germany
DE-012 Pneumologisch-Internistische Gemeinschaftspraxis Elisenhof
🇩🇪Munich, Germany
DE-010 Studienzentrum Dr. Schlenska
🇩🇪Peine, Germany
Scroll for more (49 remaining)DE-008 Lungenarztpraxis Hellersdorf🇩🇪Berlin, Germany