Study on Patterns of Care in Mild Asthmatic Patients
PRIME
A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts
1 other identifier
observational
981
4 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2022
CompletedSeptember 27, 2022
September 1, 2022
1.5 years
October 12, 2020
September 26, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (22)
To describe the Socio-demographics data of subjects with mild asthma at enrolment visit
At enrolment
To describe the clinical characteristics of subjects with mild asthma at enrolment visit
At enrolment
To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit
At enrolment
To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit
At enrolment
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
At enrolment
- +17 more secondary outcomes
Eligibility Criteria
Mild asthma patients treated by step 1 or 2 treatments according to GINA report
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Napoli, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eva Topole, Dr
CHIESI Clinical Program Leader
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2020
First Posted
October 22, 2020
Study Start
February 25, 2021
Primary Completion
September 2, 2022
Study Completion
September 2, 2022
Last Updated
September 27, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share