AsthmaTrimaximize PLNCT06567977
TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients
An observational study of Asthma, run by Chiesi Poland Sp. z o.o. at 1 site in Poland.
Trial summary
TriMaximize: 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Trimbow
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2024to 1 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult asthmatic patients
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.
Who cannot join
- Participation in an interventional clinical trial within 30 days prior to en-rolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Indywidualna Specjalistyczna Praktyka Lekarska
Tarnowskie Góry, 42-609
Szymon Płaczek, MD, 607-931-761 ext. +48, placzek@interia.pl
About this study
Official title: TriMaximize: 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.
TriMaximize: 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.
Read the detailed description
The goals of asthma therapy for all degrees of disease severity are minimising asthma symptoms, maximising lung function, and preventing asthma exacer-bations. Despite the existing treatment options and differentiated guidelines, 35 % to 45 % of the GINA 4/5 patients suffer from inadequately controlled symptoms. To investigate the cause of unsatisfactory treatment results, it is essential to monitor therapy pathways of asthma patients in a real-world set-ting. Resulting data can be compared to therapy guidelines and generate hy-potheses for future clinical trials.
Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® MS (medium strength) contains 100 µg beclomethasone whereas Trimbow® HS (high strength) contains 200 µg beclomethasone. Both formulations are investigated in this study.
Trimbow® has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow® on changes in patients' symptom burden and quality of life, adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population.
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow® in real world practice.
Secondary objectives include:
- To assess asthma control (ACT)
- To assess quality of life (Mini-AQLQ)
- To assess treatment adherence (TAI)
- To analyse parameters of lung function
- To analyse parameters of small airways disease (FEF 25-75, RV/TLC)
- To analyse parameters of asthma-related airway inflammation (FeNO)
- To analyse parameters of persistent airways limitation (reversibility testing FEV1/FVC)
- To analyse the incidence and the severity of asthma exacerbations
- To analyse the use of rescue medication
- To analyse the use of systemic corticosteroids
- To assess healthcare resource utilisation
- To assess treatment satisfaction with Trimbow®
- To assess tolerability of Trimbow® This is a non-interventional, longitudinal, international, multicentre study with prospective data collection. At baseline, the patient's medical history with spe-cial focus on asthma will be collected. The study baseline visit is at the time point of start of treatment with Trimbow®. Trimbow® treatment may have started up to a maximum of 4 weeks prior to inclusion of the patient into this NIS.
The planned observational period per patient should be at least 52 weeks (ob-servational period [OP] I of the study) and can be extended to up to 3 years (OP II of the study). During the observational period, data may be collected approximately every 3 months during the first year (OP I of the study) and thereafter every 6 months (OP II of the study). The present observational plan does not stipulate any study-related procedures or defined time points; only data that are available within the current clinical routine will be collected as documented in the patients' files.
- Conditions
- Asthma
- Being tested
- Trimbow
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimbowOther
Also called Trimbow®
Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, Glycopyrronium), a long-acting beta-adrenergic agonist (LABA, Formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® has an extra-fine formulation delivered as a controlled dosage aerosol. Trim-bow® is to be applied in accordance with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC) in each country.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice.
Primary outcome measures include:
Descriptive analisys of patients demografic
Descriptive analisys of patient demographic
Measured: 12 months
Secondary outcomes (12)
Assess asthma control (ACT)
- Assess asthma control (ACT) - Change from baseline in ACT scores
Measured: 12 months
Assess quality of life To measure the functional impairments
- Assess quality of life - Change from baseline in Mini-AQLQ scores
Measured: 12 months
Treatment adherence
- Assess treatment adherence - Change from baseline in TAI scores
Measured: 12 months
Lung function
- Analyse parameters of lung function using spirometry - Change from baseline in FEV1
Measured: 12 months
Small airways parameters
- 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
Airway inflammation
- 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
Persistent airflow limitation
- 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
Asthma exacerbations
- Analyse the incidence of asthma exacerbations - Number of exacerbations 12 months prior to baseline and during study
Measured: 12 months
Rescue medication use
- 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
Systemic corticosteroids use
- Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study
Measured: 12 months
Adverse events occurence
- Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events
Measured: 12 months
Retention rate with Trimbow
- 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 posted23 Aug 2024
- Study startAug 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Aug 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Poland Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567977
- Sponsor's protocol ID
- NIS 005 Pn
- Acronym
- Trimaximize PL
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2024
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TriMaximize: 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
- NCT06567977
- Acronym / sponsor ID
- Trimaximize PL / NIS 005 Pn
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiesi Poland Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- Aug 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Aug 2024 (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 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.
Detailed description
The goals of asthma therapy for all degrees of disease severity are minimising asthma symptoms, maximising lung function, and preventing asthma exacer-bations. Despite the existing treatment options and differentiated guidelines, 35 % to 45 % of the GINA 4/5 patients suffer from inadequately controlled symptoms. To investigate the cause of unsatisfactory treatment results, it is essential to monitor therapy pathways of asthma patients in a real-world set-ting. Resulting data can be compared to therapy guidelines and generate hy-potheses for future clinical trials.
Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® MS (medium strength) contains 100 µg beclomethasone whereas Trimbow® HS (high strength) contains 200 µg beclomethasone. Both formulations are investigated in this study.
Trimbow® has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow® on changes in patients' symptom burden and quality of life, adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population.
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow® in real world practice.
Secondary objectives include:
- To assess asthma control (ACT)
- To assess quality of life (Mini-AQLQ)
- To assess treatment adherence (TAI)
- To analyse parameters of lung function
- To analyse parameters of small airways disease (FEF 25-75, RV/TLC)
- To analyse parameters of asthma-related airway inflammation (FeNO)
- To analyse parameters of persistent airways limitation (reversibility testing FEV1/FVC)
- To analyse the incidence and the severity of asthma exacerbations
- To analyse the use of rescue medication
- To analyse the use of systemic corticosteroids
- To assess healthcare resource utilisation
- To assess treatment satisfaction with Trimbow®
- To assess tolerability of Trimbow® This is a non-interventional, longitudinal, international, multicentre study with prospective data collection. At baseline, the patient's medical history with spe-cial focus on asthma will be collected. The study baseline visit is at the time point of start of treatment with Trimbow®. Trimbow® treatment may have started up to a maximum of 4 weeks prior to inclusion of the patient into this NIS.
The planned observational period per patient should be at least 52 weeks (ob-servational period [OP] I of the study) and can be extended to up to 3 years (OP II of the study). During the observational period, data may be collected approximately every 3 months during the first year (OP I of the study) and thereafter every 6 months (OP II of the study). The present observational plan does not stipulate any study-related procedures or defined time points; only data that are available within the current clinical routine will be collected as documented in the patients' files.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult asthmatic patients
Key inclusion criteria (4 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.
Key exclusion criteria (1 listed)
- Participation in an interventional clinical trial within 30 days prior to en-rolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
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 |
|---|---|---|
| TrimbowAlso: Trimbow®Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, Glycopyrronium), a long-acting beta-adrenergic agonist (LABA, Formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® has an extra-fine formulation delivered as a controlled dosage aerosol. Trim-bow® is to be applied in accordance with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC) in each country. | Other | – |
Primary outcome
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice.
Time frame: 12 months
Primary outcome measures include: Descriptive analisys of patients demografic Descriptive analisys of patient demographic
12 secondary outcomes
Assess asthma control (ACT)
Time frame: 12 months
Assess quality of life To measure the functional impairments
Time frame: 12 months
Treatment adherence
Time frame: 12 months
Lung function
Time frame: 12 months
Small airways parameters
Time frame: 12 months
Airway inflammation
Time frame: 12 months
Persistent airflow limitation
Time frame: 12 months
Asthma exacerbations
Time frame: 12 months
Rescue medication use
Time frame: 12 months
Systemic corticosteroids use
Time frame: 12 months
Adverse events occurence
Time frame: 12 months
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 23 Aug 2024.
- 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.
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 Poland Sp. z o.o. at 1 site in Poland.
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 1 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 23 Aug 2024. 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 Poland. 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 Tomasz Debowski, Md Phd (+48-800 506 122 982, t.debowski@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to describe patient characteristics and therapy path-ways 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 23 Aug 2024.