ASTHMANCT05728749
A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
An observational study of ASTHMA, run by Chiesi SAS at 1 site in France.
Trial summary
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASTHMA
- What is being tested?
- Non-interventional
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2023to Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC). Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database. Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent.
Who may be able to join
- Patients ≥ 18 years of age,
- Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
- Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,
- Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study,
- Patient must be covered by a social security scheme,
- Patient must be treated by one of the practitioners of the centre (at office or at hospital).
Who cannot join
- Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
- Patients unable to understand scope of study or patients unwilling to participate in study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ChiesiFrance
Bois-Colombes, 92270
Christine CONTRE, Dr, c.contre@chiesi.com
Justine FIOCCA, PHARM.D, j.fiocca@chiesi.com
About this study
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
Read the detailed description
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).
Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.
In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.
- Conditions
- ASTHMA
- Being tested
- Non-interventional
- Keywords
- ASTHMA, TRIMBOW, TRIPLE THERAPY, BECLOMETHASONE, FORMOTEROL, GLYCOPYRRONIUM, TRIMAXIMIZE, REAL-WORLD SETTING, EXTRAFINE, SINGLE-INHALER, COHORT, PROSPECTIVE
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented.
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients | Trimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
Descriptive analysis of patient demographics.
Measured: 12 months
Secondary outcomes (13)
Assess asthma control (ACT)
Change from baseline in ACT scores.
Measured: 12 months
Assess quality of life
Change from baseline in Mini-AQLQ scores.
Measured: 12 months
Assess treatment adherence
Change from baseline in TAI scores.
Measured: 12 months
Analyse parameters of lung function using spirometry
Change from baseline in FEV1.
Measured: 12 months
Analyse parameters of small airways disease
Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system.
Measured: 12 months
Analyse parameters of asthma-related airway inflammation
Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb.
Measured: 12 months
Analyse parameters of persistent airflow limitation
Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7.
Measured: 12 months
Analyse the incidence of asthma exacerbations
Number of exacerbations 12 months prior to baseline and during study.
Measured: 12 months
Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations
Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study.
Measured: 12 months
Analyse use of rescue medication
Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit.
Measured: 12 months
Analyse use of systemic corticosteroids
Use of any systemic corticosteroids 12 months prior to baseline and during study.
Measured: 12 months
Assess adverse events associated with use of Trimbow
Assessment of the number and type of adverse events.
Measured: 12 months
Assess retention rate with Trimbow
Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start3 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Responsible party
- Sponsor
- Investigators
- Arnaud BOURDIN, Pr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728749
- Sponsor's protocol ID
- NIS 005 Pn
- Other IDs
- 564_TriMaximize_France
- Status last verified
- Jul 2023
- First submitted
- 6 Feb 2023
- Last updated
- 6 Jul 2023
- Results posted
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
- ClinicalTrials.gov ID
- NCT05728749
- Acronym / sponsor ID
- NIS 005 Pn
- Conditions
- ASTHMA
- Keywords
- ASTHMA, TRIMBOW, TRIPLE THERAPY, BECLOMETHASONE, FORMOTEROL, GLYCOPYRRONIUM, TRIMAXIMIZE, REAL-WORLD SETTING
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chiesi SASIndustry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Feb 2023 (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.
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
Detailed description
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).
Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.
In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma patients | – | Other: Non-interventionalTrimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC). Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database. Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent.
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age,
- Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
- Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,
- Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study,
- Patient must be covered by a social security scheme,
Key exclusion criteria (2 listed)
- Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
- Patients unable to understand scope of study or patients unwilling to participate in study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalAs this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented. | Other | Asthma patients |
Primary outcome
To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
Time frame: 12 months
Descriptive analysis of patient demographics.
13 secondary outcomes
Assess asthma control (ACT)
Time frame: 12 months
Assess quality of life
Time frame: 12 months
Assess treatment adherence
Time frame: 12 months
Analyse parameters of lung function using spirometry
Time frame: 12 months
Analyse parameters of small airways disease
Time frame: 12 months
Analyse parameters of asthma-related airway inflammation
Time frame: 12 months
Analyse parameters of persistent airflow limitation
Time frame: 12 months
Analyse the incidence of asthma exacerbations
Time frame: 12 months
Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations
Time frame: 12 months
Analyse use of rescue medication
Time frame: 12 months
Analyse use of systemic corticosteroids
Time frame: 12 months
Assess adverse events associated with use of Trimbow
Time frame: 12 months
Assess retention rate with Trimbow
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- 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.
Arnaud BOURDIN, Pr principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASTHMA, run by Chiesi SAS at 1 site in France.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine CONTRE, Dr (+33675085149, c.contre@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice (time frame: 12 months). 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 6 Jul 2023.