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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.
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.
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| 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:
| 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):
| 6-months period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Mild asthma patients treated by step 1 or 2 treatments according to GINA report
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| Name | Affiliation | Role |
|---|---|---|
| Eva Topole, Dr | CHIESI Clinical Program Leader | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DE-008 Lungenarztpraxis Hellersdorf | Berlin | Germany | ||||
| DE-003 Praxis Pneumologie und Allergologie Dr. Ginko |
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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 |
| 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 |
| DE-002 RespiRatio / Lungenpraxis Schleswig | Schleswig | Germany |
| IT-028 Fisiopatologia Respiratoria Ospedale Ecclesiastico Miulli | Acquaviva delle Fonti | Italy |
| IT-026 SOSD Allergologia A.O.U. Ospedali Riuniti | Ancona | Italy |
| IT-005 UO Allergologia Ospedale S.Maria della Speranza | Battipaglia | 84091 | Italy |
| IT-019 UOC Pneumologia Ospedale Bellaria | Bologna | Italy |
| IT-008 Pneumologia Policlinico Universitario Mater Domini | Catanzaro | Italy |
| IT-006 SC MAR Univ A.O.U. Ospedali Riuniti Foggia | Foggia | Italy |
| IT-001 UOC Pneumologia Fondazione Cà Granda Ospedale Maggiore Policlinico | Milan | 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 | Naples | Italy |
| IT-016 SSD Intertiziopatie e Malattie del Polmone A.O.U. San Luigi Gonzaga | Orbassano | Italy |
| IT-010 Medicina del Lavoro, Mal.Respiratorie e Tossicologia Azienda Ospedaliera | Perugia | Italy |
| IT-013 UO Pneumologia A.O.U. Pisana P.O. Cisanello | Pisa | 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-022 Pneumologia Univ. A.O.U. Città della Salute e della Scienza | Torino | Italy |
| IT-003 UO Pneumologia Riabilitativa ICS Maugeri | Tradate | Italy |
| IT-018 USD Allergologia AOUI Policlinico Rossi | Verona | Italy |
| PL-012 Centrum Medyczne Pratia | Bydgoszcz | Poland |
| PL-018 Prywatny Gabinet Ewa Gawrońska-Ukleja | Bydgoszcz | Poland |
| PL-010 M2M Badania Kliniczne | Chorzów | Poland |
| PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center | Grudziądz | Poland |
| PL-005 Centrum Medyczne ALL-MED | Krakow | Poland |
| PL-001 Poradnia Alergologii i Chorób Płuc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego | Lodz | Poland |
| PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a | Lodz | Poland |
| PL-017 Gabinet Pulmonologiczny | Lodz | Poland |
| PL-004 CDT Medicus | Lubin | Poland |
| PL-009 Centrum Alergologii Sp. z o. o | Lublin | Poland |
| Pl-006 Ppl Ps Magmed | Radom | Poland |
| PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak | Szczecin | Poland |
| PL-016 NZOZ Poradnia Chorób Płuc i Alergologii | Słupsk | Poland |
| PL-003 Praktyka lekarska Marzena Justyna Mierzejewska | Warsaw | Poland |
| PL-011 Lekarze Specjaliści J.Małolepszy i Partnerzy | Wroclaw | 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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