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 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 %,
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
Trial Locations
- Locations (59)
DE-008 Lungenarztpraxis Hellersdorf
🇩🇪Berlin, Germany
DE-005 Praxis für Pneumologie und Innere Medizin
🇩🇪Fürstenwalde, Germany
DE-003 Praxis Pneumologie und Allergologie Dr. Ginko
🇩🇪Bonn, 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-009 Praxis Dr. Jansen
🇩🇪Menden, Germany
IT-028 Fisiopatologia Respiratoria Ospedale Ecclesiastico Miulli
🇮🇹Acquaviva Delle Fonti, Italy
DE-004 Fortbildungs- und Studienzentrum Innere Medizin Marburg GbR
🇩🇪Marburg, Germany
DE-002 RespiRatio / Lungenpraxis Schleswig
🇩🇪Schleswig, Germany
DE-012 Pneumologisch-Internistische Gemeinschaftspraxis Elisenhof
🇩🇪Munich, Germany
IT-026 SOSD Allergologia A.O.U. Ospedali Riuniti
🇮🇹Ancona, Italy
DE-010 Studienzentrum Dr. Schlenska
🇩🇪Peine, Germany
IT-008 Pneumologia Policlinico Universitario Mater Domini
🇮🇹Catanzaro, Italy
IT-005 UO Allergologia Ospedale S.Maria della Speranza
🇮🇹Battipaglia, Italy
IT-019 UOC Pneumologia Ospedale Bellaria
🇮🇹Bologna, Italy
IT-001 UOC Pneumologia Fondazione Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
IT-006 SC MAR Univ A.O.U. Ospedali Riuniti Foggia
🇮🇹Foggia, Italy
IT-007 Malattie Apparato Respiratorio A.O.U. Modena Policlinico
🇮🇹Modena, Italy
IT-025 Allergologia e Immunologia clinica Policlinico Casula A.O.U. Cagliari
🇮🇹Monserrato, Italy
IT-012 UOC Clinica Pneumologica A.O. dei Colli P.O. Monaldi
🇮🇹Napoli, Italy
IT-016 SSD Intertiziopatie e Malattie del Polmone A.O.U. San Luigi Gonzaga
🇮🇹Orbassano, Italy
IT-013 UO Pneumologia A.O.U. Pisana P.O. Cisanello
🇮🇹Pisa, Italy
IT-010 Medicina del Lavoro, Mal.Respiratorie e Tossicologia Azienda Ospedaliera
🇮🇹Perugia, Italy
IT-015 UOC Pneumologia Policlinico Univ. A. Gemelli
🇮🇹Roma, Italy
IT-020 UOC Pneumologia A.O.U. Sant'Andrea
🇮🇹Roma, Italy
IT-009 Pneumologia Clinica e Interventistica AOU Policlinico Universitario stabilim San Pietro
🇮🇹Sassari, Italy
IT-021 Servizio Pneumologia PTA Ospedale Busacca
🇮🇹Scicli, Italy
IT-024 Allergologia Casa della Salute
🇮🇹Scilla, Italy
IT-029 Malattie Respiratorie e Trapianto Polmonare A.O.U. Senese Policlinico Le Scotte
🇮🇹Siena, Italy
IT-017 Pneumologia Riabilitativa ICS Maugeri
🇮🇹Telese Terme, Italy
IT-003 UO Pneumologia Riabilitativa ICS Maugeri
🇮🇹Tradate, Italy
IT-022 Pneumologia Univ. A.O.U. Città della Salute e della Scienza
🇮🇹Torino, Italy
IT-018 USD Allergologia AOUI Policlinico Rossi
🇮🇹Verona, Italy
PL-012 Centrum Medyczne Pratia
🇵🇱Bydgoszcz, Poland
PL-010 M2M Badania Kliniczne
🇵🇱Chorzów, Poland
PL-018 Prywatny Gabinet Ewa Gawrońska-Ukleja
🇵🇱Bydgoszcz, Poland
PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center
🇵🇱Grudziądz, Poland
PL-004 CDT Medicus
🇵🇱Lubin, Poland
PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak
🇵🇱Szczecin, Poland
PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a
🇵🇱Łódź, Poland
ES-005
🇪🇸Badalona, Spain
ES-009 Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
ES-014 Hospital El Pilar
🇪🇸Barcelona, Spain
ES-002 Hospital Universitario La Princesa
🇪🇸Madrid, Spain
ES-004 'Hospital Universitario La Paz
🇪🇸Madrid, Spain
ES-008 Fundación Jiménez Díaz
🇪🇸Madrid, Spain
ES-010 Hospital Costa del Sol
🇪🇸Málaga, Spain
ES-007 Complejo asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
ES-11 Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
ES-003 Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
PL-016 NZOZ Poradnia Chorób Płuc i Alergologii
🇵🇱Słupsk, Poland
PL-011 Lekarze Specjaliści J.Małolepszy i Partnerzy
🇵🇱Wrocław, Poland
PL-005 Centrum Medyczne ALL-MED
🇵🇱Kraków, Poland
PL-009 Centrum Alergologii Sp. z o. o
🇵🇱Lublin, Poland
PL-017 Gabinet Pulmonologiczny
🇵🇱Łódź, Poland
Pl-006 Ppl Ps Magmed
🇵🇱Radom, Poland
PL-001 Poradnia Alergologii i Chorób Płuc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego
🇵🇱Łódź, Poland
PL-003 Praktyka lekarska Marzena Justyna Mierzejewska
🇵🇱Warsaw, Poland