Clinical trial NCT04598555: Study on Patterns of Care in Mild Asthmatic Patients
Official title: A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 981
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild asthma patients treated by step 1 or 2 treatments according to GINA report

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.

Eligibility criteria: 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

Primary outcomes:
measure: To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
timeFrame: 6-months period
measure: To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
timeFrame: 6-months period
measure: To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
timeFrame: 6-months period
measure: To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
timeFrame: 6-months period
Secondary outcomes:
measure: To describe the Socio-demographics data of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the clinical characteristics of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the asthma exacerbations of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the prior asthma treatment of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the clinical characteristics of subjects with mild asthma at enrolment visit
timeFrame: At enrolment
measure: To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe subjects' level of asthma symptoms control by means of the Asthma Control Test (ACT) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe subjects' level of asthma symptoms control by means of the Asthma Control Questionnaire (ACQ-5) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe the occurrence of asthma exacerbations during the 6-month observational period
timeFrame: 6-months period
measure: To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period
timeFrame: 6-months period
measure: To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period
timeFrame: 6-months period
measure: To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period
timeFrame: 6-months period
measure: To describe the subjects' quality of life by means of the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) during the 6-month observational period
timeFrame: At enrolment and at 6-month
measure: To describe the occurrence of adverse drug reactions (ADRs) in subjects with mild asthma during the 6-month observational period.
timeFrame: 6-month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: DE-008 Lungenarztpraxis Hellersdorf
city: Bonn
country: Germany
facility: DE-003 Praxis Pneumologie und Allergologie Dr. Ginko
city: Fürstenwalde
country: Germany
facility: DE-005 Praxis für Pneumologie und Innere Medizin
city: Halle
country: Germany
facility: DE-006 Studieninstitut des Pneumologicums Halle
city: Leipzig
country: Germany
facility: DE-001 Salvus - Klinische Studien GmbH
city: Leipzig
country: Germany
facility: DE-007 POIS Leipzig GbR
city: Marburg
country: Germany
facility: DE-004 Fortbildungs- und Studienzentrum Innere Medizin Marburg GbR
city: Menden
country: Germany
facility: DE-009 Praxis Dr. Jansen
city: Munich
country: Germany
facility: DE-012 Pneumologisch-Internistische Gemeinschaftspraxis Elisenhof
city: Peine
country: Germany
facility: DE-010 Studienzentrum Dr. Schlenska
city: Schleswig
country: Germany
facility: DE-002 RespiRatio / Lungenpraxis Schleswig
city: Acquaviva Delle Fonti
country: Italy
facility: IT-028 Fisiopatologia Respiratoria Ospedale Ecclesiastico Miulli
city: Ancona
country: Italy
facility: IT-026 SOSD Allergologia A.O.U. Ospedali Riuniti
city: Battipaglia
country: Italy
facility: IT-005 UO Allergologia Ospedale S.Maria della Speranza
city: Bologna
country: Italy
facility: IT-019 UOC Pneumologia Ospedale Bellaria
city: Catanzaro
country: Italy
facility: IT-008 Pneumologia Policlinico Universitario Mater Domini
city: Foggia
country: Italy
facility: IT-006 SC MAR Univ A.O.U. Ospedali Riuniti Foggia
city: Milan
country: Italy
facility: IT-001 UOC Pneumologia Fondazione Cà Granda Ospedale Maggiore Policlinico
city: Modena
country: Italy
facility: IT-007 Malattie Apparato Respiratorio A.O.U. Modena Policlinico
city: Monserrato
country: Italy
facility: IT-025 Allergologia e Immunologia clinica Policlinico Casula A.O.U. Cagliari
city: Napoli
country: Italy
facility: IT-012 UOC Clinica Pneumologica A.O. dei Colli P.O. Monaldi
city: Orbassano
country: Italy
facility: IT-016 SSD Intertiziopatie e Malattie del Polmone A.O.U. San Luigi Gonzaga
city: Perugia
country: Italy
facility: IT-010 Medicina del Lavoro, Mal.Respiratorie e Tossicologia Azienda Ospedaliera
city: Pisa
country: Italy
facility: IT-013 UO Pneumologia A.O.U. Pisana P.O. Cisanello
city: Roma
country: Italy
facility: IT-015 UOC Pneumologia Policlinico Univ. A. Gemelli
city: Roma
country: Italy
facility: IT-020 UOC Pneumologia A.O.U. Sant'Andrea
city: Sassari
country: Italy
facility: IT-009 Pneumologia Clinica e Interventistica AOU Policlinico Universitario stabilim San Pietro
city: Scicli
country: Italy
facility: IT-021 Servizio Pneumologia PTA Ospedale Busacca
city: Scilla
country: Italy
facility: IT-024 Allergologia Casa della Salute
city: Siena
country: Italy
facility: IT-029 Malattie Respiratorie e Trapianto Polmonare A.O.U. Senese Policlinico Le Scotte
city: Telese Terme
country: Italy
facility: IT-017 Pneumologia Riabilitativa ICS Maugeri
city: Torino
country: Italy
facility: IT-022 Pneumologia Univ. A.O.U. Città della Salute e della Scienza
city: Tradate
country: Italy
facility: IT-003 UO Pneumologia Riabilitativa ICS Maugeri
city: Verona
country: Italy
facility: IT-018 USD Allergologia AOUI Policlinico Rossi
city: Bydgoszcz
country: Poland
facility: PL-012 Centrum Medyczne Pratia
city: Bydgoszcz
country: Poland
facility: PL-018 Prywatny Gabinet Ewa Gawrońska-Ukleja
city: Chorzów
country: Poland
facility: PL-010 M2M Badania Kliniczne
city: Grudziądz
country: Poland
facility: PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center
city: Kraków
country: Poland
facility: PL-005 Centrum Medyczne ALL-MED
city: Lubin
country: Poland
facility: PL-004 CDT Medicus
city: Lublin
country: Poland
facility: PL-009 Centrum Alergologii Sp. z o. o
city: Radom
country: Poland
facility: Pl-006 Ppl Ps Magmed
city: Szczecin
country: Poland
facility: PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak
city: Słupsk
country: Poland
facility: PL-016 NZOZ Poradnia Chorób Płuc i Alergologii
city: Warsaw
country: Poland
facility: PL-003 Praktyka lekarska Marzena Justyna Mierzejewska
city: Wrocław
country: Poland
facility: PL-011 Lekarze Specjaliści J.Małolepszy i Partnerzy
city: Łódź
country: Poland
facility: PL-001 Poradnia Alergologii i Chorób Płuc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego
city: Łódź
country: Poland
facility: PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a
city: Łódź
country: Poland
facility: PL-017 Gabinet Pulmonologiczny
city: Badalona
country: Spain
facility: ES-005
city: Barcelona
country: Spain
facility: ES-009 Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: ES-014 Hospital El Pilar
city: Madrid
country: Spain
facility: ES-002 Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: ES-004 'Hospital Universitario La Paz
city: Madrid
country: Spain
facility: ES-008 Fundación Jiménez Díaz
city: Málaga
country: Spain
facility: ES-010 Hospital Costa del Sol
city: Salamanca
country: Spain
facility: ES-007 Complejo asistencial Universitario de Salamanca
city: Santander
country: Spain
facility: ES-11 Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: ES-003 Hospital Universitario Dr. Peset
Study officials:
affiliation: CHIESI Clinical Program Leader
name: Eva Topole, Dr
role: STUDY_DIRECTOR
References: