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

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.

Study Overview

• Status: Completed
• Conditions: Asthma

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.

• Study Type: Observational
• Enrollment (Actual): 981

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • DE-008 Lungenarztpraxis Hellersdorf
  • Bonn, Germany
    • DE-003 Praxis Pneumologie und Allergologie Dr. Ginko
  • Fürstenwalde, Germany
    • DE-005 Praxis für Pneumologie und Innere Medizin
  • Halle, Germany
    • DE-006 Studieninstitut des Pneumologicums Halle
  • Leipzig, Germany
    • DE-001 Salvus - Klinische Studien GmbH
  • Leipzig, Germany
    • DE-007 POIS Leipzig GbR
  • Marburg, Germany
    • DE-004 Fortbildungs- und Studienzentrum Innere Medizin Marburg GbR
  • Menden, Germany
    • DE-009 Praxis Dr. Jansen
  • Munich, Germany
    • DE-012 Pneumologisch-Internistische Gemeinschaftspraxis Elisenhof
  • Peine, Germany
    • DE-010 Studienzentrum Dr. Schlenska
  • Schleswig, Germany
    • DE-002 RespiRatio / Lungenpraxis Schleswig
• Italy
  • Acquaviva Delle Fonti, Italy
    • IT-028 Fisiopatologia Respiratoria Ospedale Ecclesiastico Miulli
  • Ancona, Italy
    • IT-026 SOSD Allergologia A.O.U. Ospedali Riuniti
  • Battipaglia, Italy, 84091
    • IT-005 UO Allergologia Ospedale S.Maria della Speranza
  • Bologna, Italy
    • IT-019 UOC Pneumologia Ospedale Bellaria
  • Catanzaro, Italy
    • IT-008 Pneumologia Policlinico Universitario Mater Domini
  • Foggia, Italy
    • IT-006 SC MAR Univ A.O.U. Ospedali Riuniti Foggia
  • Milan, Italy
    • IT-001 UOC Pneumologia Fondazione Cà Granda Ospedale Maggiore Policlinico
  • Modena, Italy
    • IT-007 Malattie Apparato Respiratorio A.O.U. Modena Policlinico
  • Monserrato, Italy
    • IT-025 Allergologia e Immunologia clinica Policlinico Casula A.O.U. Cagliari
  • Napoli, Italy
    • IT-012 UOC Clinica Pneumologica A.O. dei Colli P.O. Monaldi
  • Orbassano, Italy
    • IT-016 SSD Intertiziopatie e Malattie del Polmone A.O.U. San Luigi Gonzaga
  • Perugia, Italy
    • IT-010 Medicina del Lavoro, Mal.Respiratorie e Tossicologia Azienda Ospedaliera
  • Pisa, Italy
    • IT-013 UO Pneumologia A.O.U. Pisana P.O. Cisanello
  • Roma, Italy
    • IT-015 UOC Pneumologia Policlinico Univ. A. Gemelli
  • Roma, Italy
    • IT-020 UOC Pneumologia A.O.U. Sant'Andrea
  • Sassari, Italy
    • IT-009 Pneumologia Clinica e Interventistica AOU Policlinico Universitario stabilim San Pietro
  • Scicli, Italy
    • IT-021 Servizio Pneumologia PTA Ospedale Busacca
  • Scilla, Italy
    • IT-024 Allergologia Casa della Salute
  • Siena, Italy
    • IT-029 Malattie Respiratorie e Trapianto Polmonare A.O.U. Senese Policlinico Le Scotte
  • Telese Terme, Italy
    • IT-017 Pneumologia Riabilitativa ICS Maugeri
  • Torino, Italy
    • IT-022 Pneumologia Univ. A.O.U. Città della Salute e della Scienza
  • Tradate, Italy
    • IT-003 UO Pneumologia Riabilitativa ICS Maugeri
  • Verona, Italy
    • IT-018 USD Allergologia AOUI Policlinico Rossi
• Poland
  • Bydgoszcz, Poland
    • PL-012 Centrum Medyczne Pratia
  • Bydgoszcz, Poland
    • PL-018 Prywatny Gabinet Ewa Gawrońska-Ukleja
  • Chorzów, Poland
    • PL-010 M2M Badania Kliniczne
  • Grudziądz, Poland
    • PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center
  • Kraków, Poland
    • PL-005 Centrum Medyczne ALL-MED
  • Lubin, Poland
    • PL-004 CDT Medicus
  • Lublin, Poland
    • PL-009 Centrum Alergologii Sp. z o. o
  • Radom, Poland
    • Pl-006 Ppl Ps Magmed
  • Szczecin, Poland
    • PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak
  • Słupsk, Poland
    • PL-016 NZOZ Poradnia Chorób Płuc i Alergologii
  • Warsaw, Poland
    • PL-003 Praktyka lekarska Marzena Justyna Mierzejewska
  • Wrocław, Poland
    • PL-011 Lekarze Specjaliści J.Małolepszy i Partnerzy
  • Łódź, Poland
    • PL-001 Poradnia Alergologii i Chorób Płuc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego
  • Łódź, Poland
    • PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a
  • Łódź, Poland
    • PL-017 Gabinet Pulmonologiczny
• Spain
  • Badalona, Spain
    • ES-005
  • Barcelona, Spain
    • ES-009 Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • ES-014 Hospital El Pilar
  • Madrid, Spain
    • ES-002 Hospital Universitario La Princesa
  • Madrid, Spain
    • ES-004 'Hospital Universitario La Paz
  • Madrid, Spain
    • ES-008 Fundación Jiménez Díaz
  • Málaga, Spain
    • ES-010 Hospital Costa del Sol
  • Salamanca, Spain
    • ES-007 Complejo asistencial Universitario de Salamanca
  • Santander, Spain
    • ES-11 Hospital Universitario Marqués de Valdecilla
  • Valencia, Spain
    • ES-003 Hospital Universitario Dr. Peset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mild asthma patients treated by step 1 or 2 treatments according to GINA report

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Study Director: Eva Topole, Dr, CHIESI Clinical Program Leader

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2021
• Primary Completion (ACTUAL): September 2, 2022
• Study Completion (ACTUAL): September 2, 2022

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CLI-01535AA0-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No