Study on Patterns of Care in Mild Asthmatic Patients

NCT ID: NCT04598555

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

981 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-25

Study Completion Date

2022-09-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Topole, Dr

Role: STUDY_DIRECTOR

CHIESI Clinical Program Leader

Locations

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DE-008 Lungenarztpraxis Hellersdorf

Berlin, , Germany

Site Status

DE-003 Praxis Pneumologie und Allergologie Dr. Ginko

Bonn, , Germany

Site Status

DE-005 Praxis für Pneumologie und Innere Medizin

Fürstenwalde, , Germany

Site Status

DE-006 Studieninstitut des Pneumologicums Halle

Halle, , Germany

Site Status

DE-001 Salvus - Klinische Studien GmbH

Leipzig, , Germany

Site Status

DE-007 POIS Leipzig GbR

Leipzig, , Germany

Site Status

DE-004 Fortbildungs- und Studienzentrum Innere Medizin Marburg GbR

Marburg, , Germany

Site Status

DE-009 Praxis Dr. Jansen

Menden, , Germany

Site Status

DE-012 Pneumologisch-Internistische Gemeinschaftspraxis Elisenhof

Munich, , Germany

Site Status

DE-010 Studienzentrum Dr. Schlenska

Peine, , Germany

Site Status

DE-002 RespiRatio / Lungenpraxis Schleswig

Schleswig, , Germany

Site Status

IT-028 Fisiopatologia Respiratoria Ospedale Ecclesiastico Miulli

Acquaviva delle Fonti, , Italy

Site Status

IT-026 SOSD Allergologia A.O.U. Ospedali Riuniti

Ancona, , Italy

Site Status

IT-005 UO Allergologia Ospedale S.Maria della Speranza

Battipaglia, , Italy

Site Status

IT-019 UOC Pneumologia Ospedale Bellaria

Bologna, , Italy

Site Status

IT-008 Pneumologia Policlinico Universitario Mater Domini

Catanzaro, , Italy

Site Status

IT-006 SC MAR Univ A.O.U. Ospedali Riuniti Foggia

Foggia, , Italy

Site Status

IT-001 UOC Pneumologia Fondazione Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

IT-007 Malattie Apparato Respiratorio A.O.U. Modena Policlinico

Modena, , Italy

Site Status

IT-025 Allergologia e Immunologia clinica Policlinico Casula A.O.U. Cagliari

Monserrato, , Italy

Site Status

IT-012 UOC Clinica Pneumologica A.O. dei Colli P.O. Monaldi

Napoli, , Italy

Site Status

IT-016 SSD Intertiziopatie e Malattie del Polmone A.O.U. San Luigi Gonzaga

Orbassano, , Italy

Site Status

IT-010 Medicina del Lavoro, Mal.Respiratorie e Tossicologia Azienda Ospedaliera

Perugia, , Italy

Site Status

IT-013 UO Pneumologia A.O.U. Pisana P.O. Cisanello

Pisa, , Italy

Site Status

IT-015 UOC Pneumologia Policlinico Univ. A. Gemelli

Roma, , Italy

Site Status

IT-020 UOC Pneumologia A.O.U. Sant'Andrea

Roma, , Italy

Site Status

IT-009 Pneumologia Clinica e Interventistica AOU Policlinico Universitario stabilim San Pietro

Sassari, , Italy

Site Status

IT-021 Servizio Pneumologia PTA Ospedale Busacca

Scicli, , Italy

Site Status

IT-024 Allergologia Casa della Salute

Scilla, , Italy

Site Status

IT-029 Malattie Respiratorie e Trapianto Polmonare A.O.U. Senese Policlinico Le Scotte

Siena, , Italy

Site Status

IT-017 Pneumologia Riabilitativa ICS Maugeri

Telese Terme, , Italy

Site Status

IT-022 Pneumologia Univ. A.O.U. Città della Salute e della Scienza

Torino, , Italy

Site Status

IT-003 UO Pneumologia Riabilitativa ICS Maugeri

Tradate, , Italy

Site Status

IT-018 USD Allergologia AOUI Policlinico Rossi

Verona, , Italy

Site Status

PL-012 Centrum Medyczne Pratia

Bydgoszcz, , Poland

Site Status

PL-018 Prywatny Gabinet Ewa Gawrońska-Ukleja

Bydgoszcz, , Poland

Site Status

PL-010 M2M Badania Kliniczne

Chorzów, , Poland

Site Status

PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center

Grudziądz, , Poland

Site Status

PL-005 Centrum Medyczne ALL-MED

Krakow, , Poland

Site Status

PL-001 Poradnia Alergologii i Chorób Płuc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego

Lodz, , Poland

Site Status

PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a

Lodz, , Poland

Site Status

PL-017 Gabinet Pulmonologiczny

Lodz, , Poland

Site Status

PL-004 CDT Medicus

Lubin, , Poland

Site Status

PL-009 Centrum Alergologii Sp. z o. o

Lublin, , Poland

Site Status

Pl-006 Ppl Ps Magmed

Radom, , Poland

Site Status

PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak

Szczecin, , Poland

Site Status

PL-016 NZOZ Poradnia Chorób Płuc i Alergologii

Słupsk, , Poland

Site Status

PL-003 Praktyka lekarska Marzena Justyna Mierzejewska

Warsaw, , Poland

Site Status

PL-011 Lekarze Specjaliści J.Małolepszy i Partnerzy

Wroclaw, , Poland

Site Status

ES-005

Badalona, , Spain

Site Status

ES-009 Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

ES-014 Hospital El Pilar

Barcelona, , Spain

Site Status

ES-002 Hospital Universitario La Princesa

Madrid, , Spain

Site Status

ES-004 'Hospital Universitario La Paz

Madrid, , Spain

Site Status

ES-008 Fundación Jiménez Díaz

Madrid, , Spain

Site Status

ES-010 Hospital Costa del Sol

Málaga, , Spain

Site Status

ES-007 Complejo asistencial Universitario de Salamanca

Salamanca, , Spain

Site Status

ES-11 Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

ES-003 Hospital Universitario Dr. Peset

Valencia, , Spain

Site Status

Countries

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Germany Italy Poland Spain

Other Identifiers

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CLI-01535AA0-01

Identifier Type: -

Identifier Source: org_study_id

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