Study on Patterns of Care in Mild Asthmatic Patients

Asthma Clinical Trial

— PRIME  

Official title:

A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598555
• Other study ID #: CLI-01535AA0-01
• Status: Completed
• Start date: February 25, 2021
• Est. completion date: September 2, 2022

Study information

• Verified date: September 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 981
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Germany	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
Italy	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
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
Poland	PL-012 Centrum Medyczne Pratia	Bydgoszcz
Poland	PL-018 Prywatny Gabinet Ewa Gawronska-Ukleja	Bydgoszcz
Poland	PL-010 M2M Badania Kliniczne	Chorzów
Poland	PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center	Grudziadz
Poland	PL-005 Centrum Medyczne ALL-MED	Kraków
Poland	PL-001 Poradnia Alergologii i Chorób Pluc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego	Lódz
Poland	PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a	Lódz
Poland	PL-017 Gabinet Pulmonologiczny	Lódz
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-016 NZOZ Poradnia Chorób Pluc i Alergologii	Slupsk
Poland	PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak	Szczecin
Poland	PL-003 Praktyka lekarska Marzena Justyna Mierzejewska	Warsaw
Poland	PL-011 Lekarze Specjalisci J.Malolepszy i Partnerzy	Wroclaw
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	To describe the Socio-demographics data of subjects with mild asthma at enrolment visit	BMI in kg/m^2	At enrolment
Secondary	To describe the clinical characteristics of subjects with mild asthma at enrolment visit	Lifestyle and smoking habits data description	At enrolment
Secondary	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
Secondary	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
Secondary	To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit	Time from first Asthma Diagnosis	At enrolment
Secondary	To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit	Type of diagnosis strategy	At enrolment
Secondary	To describe the asthma exacerbations of subjects with mild asthma at enrolment visit	Asthma exacerbations history data description	At enrolment
Secondary	To describe the prior asthma treatment of subjects with mild asthma at enrolment visit	Type of prior Asthma treatments description	At enrolment
Secondary	To describe the clinical characteristics of subjects with mild asthma at enrolment visit	Skin Prick test data description	At enrolment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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