AsthmaPRIMENCT04598555
Study on Patterns of Care in Mild Asthmatic Patients
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A. at 59 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- How many people
- 981 participants
- Where
- 59 sitesin 4 countries
- Study dates
- 25 Feb 2021to 2 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mild asthma patients treated by step 1 or 2 treatments according to GINA report
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
59 sites in 4 countries.
59 sites in 4 countries
Italy23 sites
IT-028 Fisiopatologia Respiratoria Ospedale Ecclesiastico Miulli
Acquaviva delle Fonti
IT-026 SOSD Allergologia A.O.U. Ospedali Riuniti
Ancona
IT-005 UO Allergologia Ospedale S.Maria della Speranza
Battipaglia, 84091
IT-019 UOC Pneumologia Ospedale Bellaria
Bologna
IT-008 Pneumologia Policlinico Universitario Mater Domini
Catanzaro
IT-006 SC MAR Univ A.O.U. Ospedali Riuniti Foggia
Foggia
IT-001 UOC Pneumologia Fondazione Cà Granda Ospedale Maggiore Policlinico
Milan
IT-007 Malattie Apparato Respiratorio A.O.U. Modena Policlinico
Modena
IT-025 Allergologia e Immunologia clinica Policlinico Casula A.O.U. Cagliari
Monserrato
IT-012 UOC Clinica Pneumologica A.O. dei Colli P.O. Monaldi
Naples
IT-016 SSD Intertiziopatie e Malattie del Polmone A.O.U. San Luigi Gonzaga
Orbassano
IT-010 Medicina del Lavoro, Mal.Respiratorie e Tossicologia Azienda Ospedaliera
Perugia
IT-013 UO Pneumologia A.O.U. Pisana P.O. Cisanello
Pisa
IT-015 UOC Pneumologia Policlinico Univ. A. Gemelli
Roma
IT-020 UOC Pneumologia A.O.U. Sant'Andrea
Roma
IT-009 Pneumologia Clinica e Interventistica AOU Policlinico Universitario stabilim San Pietro
Sassari
IT-021 Servizio Pneumologia PTA Ospedale Busacca
Scicli
IT-024 Allergologia Casa della Salute
Scilla
IT-029 Malattie Respiratorie e Trapianto Polmonare A.O.U. Senese Policlinico Le Scotte
Siena
IT-017 Pneumologia Riabilitativa ICS Maugeri
Telese Terme
IT-022 Pneumologia Univ. A.O.U. Città della Salute e della Scienza
Torino
IT-003 UO Pneumologia Riabilitativa ICS Maugeri
Tradate
IT-018 USD Allergologia AOUI Policlinico Rossi
Verona
Poland15 sites
PL-012 Centrum Medyczne Pratia
Bydgoszcz
PL-018 Prywatny Gabinet Ewa Gawrońska-Ukleja
Bydgoszcz
PL-010 M2M Badania Kliniczne
Chorzów
PL-015 Prywatny gabinet Pulmonologiczny at premises of Amicmed Medical Center
Grudziądz
PL-005 Centrum Medyczne ALL-MED
Krakow
PL-001 Poradnia Alergologii i Chorób Płuc, SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego
Lodz
PL-013 SNZOZ Poradnia Specjalistyczna MedMed, Ul. Brzechwy 7a
Lodz
PL-017 Gabinet Pulmonologiczny
Lodz
PL-004 CDT Medicus
Lubin
PL-009 Centrum Alergologii Sp. z o. o
Lublin
Pl-006 Ppl Ps Magmed
Radom
PL-016 NZOZ Poradnia Chorób Płuc i Alergologii
Słupsk
PL-014 Indywidualna Specjalistyczna Praktyka Lekarska Marzenna Tarnowska-Matusiak
Szczecin
PL-003 Praktyka lekarska Marzena Justyna Mierzejewska
Warsaw
PL-011 Lekarze Specjaliści J.Małolepszy i Partnerzy
Wroclaw
Germany11 sites
DE-008 Lungenarztpraxis Hellersdorf
Berlin
DE-003 Praxis Pneumologie und Allergologie Dr. Ginko
Bonn
DE-005 Praxis für Pneumologie und Innere Medizin
Fürstenwalde
DE-006 Studieninstitut des Pneumologicums Halle
Halle
DE-001 Salvus - Klinische Studien GmbH
Leipzig
DE-007 POIS Leipzig GbR
Leipzig
DE-004 Fortbildungs- und Studienzentrum Innere Medizin Marburg GbR
Marburg
DE-009 Praxis Dr. Jansen
Menden
DE-012 Pneumologisch-Internistische Gemeinschaftspraxis Elisenhof
Munich
DE-010 Studienzentrum Dr. Schlenska
Peine
DE-002 RespiRatio / Lungenpraxis Schleswig
Schleswig
Spain10 sites
ES-005
Badalona
ES-009 Hospital de la Santa Creu i Sant Pau
Barcelona
ES-014 Hospital El Pilar
Barcelona
ES-002 Hospital Universitario La Princesa
Madrid
ES-004 'Hospital Universitario La Paz
Madrid
ES-008 Fundación Jiménez Díaz
Madrid
ES-010 Hospital Costa del Sol
Málaga
ES-007 Complejo asistencial Universitario de Salamanca
Salamanca
ES-11 Hospital Universitario Marqués de Valdecilla
Santander
ES-003 Hospital Universitario Dr. Peset
Valencia
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 6-months period
Secondary outcomes (22)
To describe the Socio-demographics data of subjects with mild asthma at enrolment visit
BMI in kg/m^2
Measured: At enrolment
To describe the clinical characteristics of subjects with mild asthma at enrolment visit
Lifestyle and smoking habits data description
Measured: 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
Measured: 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
Measured: At enrolment
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
Time from first Asthma Diagnosis
Measured: At enrolment
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
Type of diagnosis strategy
Measured: At enrolment
To describe the asthma exacerbations of subjects with mild asthma at enrolment visit
Asthma exacerbations history data description
Measured: At enrolment
To describe the prior asthma treatment of subjects with mild asthma at enrolment visit
Type of prior Asthma treatments description
Measured: At enrolment
To describe the clinical characteristics of subjects with mild asthma at enrolment visit
Skin Prick test data description
Measured: 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
Measured: 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 %,
Measured: 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
Measured: 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
Measured: 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 %
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start25 Feb 2021
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 981 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Topole, Dr, Study director, CHIESI Clinical Program Leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598555
- Sponsor's protocol ID
- CLI-01535AA0-01
- Acronym
- PRIME
- Status last verified
- Sep 2022
- First submitted
- 12 Oct 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts
- ClinicalTrials.gov ID
- NCT04598555
- Acronym / sponsor ID
- PRIME / CLI-01535AA0-01
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 981 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild asthma patients treated by step 1 or 2 treatments according to GINA report
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
Time frame: 6-months period
Frequency of asthma treatments for asthma management, regardless the duration: * by active substance * by drug class * distinguishing between "controller" and "reliever" treatments
To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
Time frame: 6-months 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)
To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
Time frame: 6-months period
Frequency of treatment posology, stratified by type of asthma treatment
To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
Time frame: 6-months 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.
22 secondary outcomes
To describe the Socio-demographics data of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the clinical characteristics of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the asthma exacerbations of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the prior asthma treatment of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the clinical characteristics of subjects with mild asthma at enrolment visit
Time frame: At enrolment
To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period
Time frame: At enrolment and at 6-month
To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period
Time frame: At enrolment and at 6-month
To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period
Time frame: At enrolment and at 6-month
To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period
Time frame: At enrolment and at 6-month
To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period
Time frame: 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
Time frame: 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
Time frame: At enrolment and at 6-month
To describe the occurrence of asthma exacerbations during the 6-month observational period
Time frame: 6-months period
To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period
Time frame: 6-months period
To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period
Time frame: 6-months period
To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period
Time frame: 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
Time frame: 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.
Time frame: 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Topole, Dr study director
CHIESI Clinical Program Leader
59 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A. at 59 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Italy, Poland, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period. (time frame: 6-months period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.