COPDTriNEXTNCT05948891
Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study
An observational study of COPD, run by Chiesi SAS at 1 site in France.
Trial summary
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients participating in this non-interventional real-world evidence study will be COPD patients for whom it has been decided to initiate BDP/FF/G (88/5/9) in NEXThaler® device by a physician in accordance with clinical practice All eligible patients should be offered enrolment for data collection within the study. Participating sites will be encouraged to propose the study to all patients satisfying eligibility criteria, in a consecutive manner, when patients come for their regular consultation, in order to minimize bias in patient selection. In any case, the treatment decision must have been taken by the investigator prior to, and independently of the patient's inclusion into the study, following standard clinical practice and regulations.
Who may be able to join
- Male or female patients aged ≥40 years
- Diagnosis of COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7
- Physicians' decision to start a first prescription fixed triple therapy with BDP/FF/GB NEXThaler® 88/5/9 in accordance with the marketing authorization
- COPD Assessment Test (CAT) total score of at least 10 at the day of inclusion
- Informed consent to participate in the study
Who cannot join
- Asthmatic patients
- Patients with moderate or severe exacerbations within the 4 weeks prior to enrolment
- Patients treated with fixed triple therapies within 6 months prior inclusion
- Patients receiving pulmonary rehabilitation within 3 months prior to inclusion or within 6 months after inclusion
- Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study
Trial locations and contacts
1 site in 1 country.
Justine Fiocca, PHARM.D-Medical Advisor contact
About this study
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting. Patients enrolled in this study will be patients diagnosed with a COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7 to whom TRIMBOW NEXThaler 88/5/9 has been initiated by an hospital or local pulmonologists in accordance with clinical practice and marketing authorization.
Read the detailed description
The decision of patients to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. The treatment decision must have been taken prior to and independently of the patient's inclusion in the study. All aspects of treatment and clinical management of patients will be at the discretion of the participating pulmonologist (or treating pulmonologist where different) according to local clinical practice and applicable local regulations.
In addition to the data available per clinical practice, the participating pulmonologists will be asked to obtain patient-reported outcome measures (PROMs) data from patients within this study and to invite patients to wear a connected watch to record physical activity and sleep quality (50% of patients (about 250 patients) who first accept to wear the watch will be equipped).
The duration of a patient's participation in this study will be 6 months made of three visits (M0, M3, M6) according to routine clinical practice.
- Visit 1 (M0); inclusion of patient when BDP/FF/GB NEXThaler® 88/5/9 is initiated;
- Visit 2 (M3); 3 months (+/- 30 days) post BDP/FF/GB NEXThaler® 88/5/9 initiation;
- Visit 3 (M6, last visit): 6 months (+/- 30 days) post BDP/FF/GB NEXThaler® 88/5/9 initiation;
The inclusion duration will be 12 to 15 months. The overall duration of the study, including recruitment and follow-up, is expected to be 21 months.
Data collection will be considered complete for a participating patient if data available at 6 have been recorded in the CRF and associated PROs completed. Patients will be followed until the end of the study period (M6) even if TRIMBOW NEXThaler 88/5/9 is discontinued.
- Conditions
- COPD
- Being tested
- Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)
- Keywords
- Digital, QOL, PROMS, PRO, respiratory diseases, Chronic obstructive pulmonary disease (COPD), Adult, observational, connected device, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)Drug
observational, prospective, multicentric, international, cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of quality of life through CAT (COPD assessement tool) over 6 month period
To assess change in QoL using the CAT scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
- Primary endpoint is the proportion of patients achieving a ≥2-point reduction in CAT total score (MCID) at M6 compared to baseline.
Measured: Month 6
Secondary outcomes (12)
Mean change Quality of life through VQ11 questionnaire
To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
- Endpoint is mean VQ11 total score and sub scores described at baseline, M3 and M6
Measured: Month 0, Month 3 and Month 6
Proportion of patients achieving a ≥2-point reduction in VQ11 total score
To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
- Endpoint is the proportion of patients achieving a ≥2-point reduction in VQ11 total score (MCID) at M3 and M6 compared to baseline.
Measured: Month 0, Month 3 and Month 6
Mean change in Dyspnoea throught "Dyspnea-12 questionnaire"
To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
- Endpoint is D-12 total score and sub scores described at baseline, M3 and M6
Measured: Month 0, Month 3 and Month 6
Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score
To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
- Endpoint is the proportion of patients achieving a 3-point reduction in D-12 total score (MCID) at M3 and M6 compared to baseline.
Measured: Month 0, Month 3 and Month 6
Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF
To describe the occurrence of moderate to severe exacerbations over a 6- month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
Endpoint is the proportion of patients with at least a moderate or severe exacerbation (overall and in each category), at baseline (in the previous 12 months), M3 and M6
Measured: Month 0, Month 3 and Month 6
Proportion of patients achieving an increase in physical activity throught the a connected device
To assess changes in physical activity using a connected watch over a 6-month
- Endpoint is the proportion of patients achieving an increase in physical activity (≥ 10%-increase in the mean daily number of step) at M3 and M6 compared to baseline.
Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
Measured: Month 0, Month 3 and Month 6
Mean daily number of steps throught the a connected device
To assess changes in physical activity using a connected watch over a 6-month
- Endpoints are the mean daily number of steps and the mean of number of steps during 7 days at M0, M3 and M6
Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device
Measured: Month 0, Month 3 and Month 6
Sleep quality throught the Pittsburgh questionnaire
- Endpoints are the Pittsburgh questionnaire at M0, M3 and M6
Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing.
Measured: Month 0, Month 3 and Month 6
Sleep quality throught the a connected device
To assess changes in sleep quality using a connected device
- Endpoints are the mean daily sleep time, the mean of sleep time and the mean daily number of awakenings during 7 days at M0, M3 and M6
Baseline sleep quality (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing.
Measured: Month 0, Month 3 and Month 6
Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary
To assess treatment compliance with BDP/FF/G (88/5/9) in NEXThaler® device
- Endpoint is the description of treatment compliance global score at M3 and M6 for COPD using TAI
Measured: Month 3 and Month 6
Baseline description of sociodemographic data and medical data through eCRF
to describe COPD patient, disease and treatment characteristics at initiation of BDP/FF/G (88/5/9) in NEXThaler® device
- Endpoints are description of sociodemographic (age, sex, weight, height, education level, occupation), medical data (risk factors exposure including tobacco, disease history) and lung function data (FEV1, FVC, RV, TLC) at baseline
- Endpoints are description of comorbidities and associated treatment throughout the study at baseline
- Endpoints are description of previous COPD-related treatment at baseline through eCRF
Measured: baseline
Treatment tolerance throughout the study through eCRF
To assess treatment tolerance in COPD patients treated with with BDP/FF/G (88/5/9) in NEXThaler® device To assess patient satisfaction with treatment in COPD patients treated with BDP/FF/GB NEXThaler® 88/5/9
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Aug 2023
- Primary completionDec 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 COPDStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kappa Santé
- Responsible party
- Sponsor
- Investigators
- Capucine MORELOT PANZINI, Pr, Principal investigator, University Hospital, la pitié salpêtrièrePhilippe DEVILLIER, Pr, Principal investigator, HOSPITAL, FOCHHervé PEGLIASCO, Dr, Principal investigator, European Hospital, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948891
- Sponsor's protocol ID
- NIS 723
- Acronym
- TriNEXT
- Status last verified
- Mar 2024
- First submitted
- 30 Jun 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study
- ClinicalTrials.gov ID
- NCT05948891
- Acronym / sponsor ID
- TriNEXT / NIS 723
- Conditions
- COPD
- Keywords
- Digital, QOL, PROMS, PRO, respiratory diseases, Chronic obstructive pulmonary disease (COPD), Adult, observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chiesi SASIndustry (pharma, biotech, devices)
- Collaborators
- Kappa Santé
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Jul 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.
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting. Patients enrolled in this study will be patients diagnosed with a COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7 to whom TRIMBOW NEXThaler 88/5/9 has been initiated by an hospital or local pulmonologists in accordance with clinical practice and marketing authorization.
Detailed description
The decision of patients to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. The treatment decision must have been taken prior to and independently of the patient's inclusion in the study. All aspects of treatment and clinical management of patients will be at the discretion of the participating pulmonologist (or treating pulmonologist where different) according to local clinical practice and applicable local regulations.
In addition to the data available per clinical practice, the participating pulmonologists will be asked to obtain patient-reported outcome measures (PROMs) data from patients within this study and to invite patients to wear a connected watch to record physical activity and sleep quality (50% of patients (about 250 patients) who first accept to wear the watch will be equipped).
The duration of a patient's participation in this study will be 6 months made of three visits (M0, M3, M6) according to routine clinical practice.
- Visit 1 (M0); inclusion of patient when BDP/FF/GB NEXThaler® 88/5/9 is initiated;
- Visit 2 (M3); 3 months (+/- 30 days) post BDP/FF/GB NEXThaler® 88/5/9 initiation;
- Visit 3 (M6, last visit): 6 months (+/- 30 days) post BDP/FF/GB NEXThaler® 88/5/9 initiation;
The inclusion duration will be 12 to 15 months. The overall duration of the study, including recruitment and follow-up, is expected to be 21 months.
Data collection will be considered complete for a participating patient if data available at 6 have been recorded in the CRF and associated PROs completed. Patients will be followed until the end of the study period (M6) even if TRIMBOW NEXThaler 88/5/9 is discontinued.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients participating in this non-interventional real-world evidence study will be COPD patients for whom it has been decided to initiate BDP/FF/G (88/5/9) in NEXThaler® device by a physician in accordance with clinical practice All eligible patients should be offered enrolment for data collection within the study. Participating sites will be encouraged to propose the study to all patients satisfying eligibility criteria, in a consecutive manner, when patients come for their regular consultation, in order to minimize bias in patient selection. In any case, the treatment decision must have been taken by the investigator prior to, and independently of the patient's inclusion into the study, following standard clinical practice and regulations.
Key inclusion criteria (5 listed)
- Male or female patients aged ≥40 years
- Diagnosis of COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7
- Physicians' decision to start a first prescription fixed triple therapy with BDP/FF/GB NEXThaler® 88/5/9 in accordance with the marketing authorization
- COPD Assessment Test (CAT) total score of at least 10 at the day of inclusion
- Informed consent to participate in the study
Key exclusion criteria (5 listed)
- Asthmatic patients
- Patients with moderate or severe exacerbations within the 4 weeks prior to enrolment
- Patients treated with fixed triple therapies within 6 months prior inclusion
- Patients receiving pulmonary rehabilitation within 3 months prior to inclusion or within 6 months after inclusion
- Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present 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 |
|---|---|---|
| Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)observational, prospective, multicentric, international, cohort study | Drug | – |
Primary outcome
Change of quality of life through CAT (COPD assessement tool) over 6 month period
Time frame: Month 6
To assess change in QoL using the CAT scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Primary endpoint is the proportion of patients achieving a ≥2-point reduction in CAT total score (MCID) at M6 compared to baseline.
12 secondary outcomes
Mean change Quality of life through VQ11 questionnaire
Time frame: Month 0, Month 3 and Month 6
Proportion of patients achieving a ≥2-point reduction in VQ11 total score
Time frame: Month 0, Month 3 and Month 6
Mean change in Dyspnoea throught "Dyspnea-12 questionnaire"
Time frame: Month 0, Month 3 and Month 6
Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score
Time frame: Month 0, Month 3 and Month 6
Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF
Time frame: Month 0, Month 3 and Month 6
Proportion of patients achieving an increase in physical activity throught the a connected device
Time frame: Month 0, Month 3 and Month 6
Mean daily number of steps throught the a connected device
Time frame: Month 0, Month 3 and Month 6
Sleep quality throught the Pittsburgh questionnaire
Time frame: Month 0, Month 3 and Month 6
Sleep quality throught the a connected device
Time frame: Month 0, Month 3 and Month 6
Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary
Time frame: Month 3 and Month 6
Baseline description of sociodemographic data and medical data through eCRF
Time frame: baseline
Treatment tolerance throughout the study through eCRF
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Justine Fiocca, PHARM.D-Medical Advisor contact
Capucine MORELOT PANZINI, Pr principal investigator
University Hospital, la pitié salpêtrière
Philippe DEVILLIER, Pr principal investigator
HOSPITAL, FOCH
Hervé PEGLIASCO, Dr principal investigator
European Hospital, Marseille
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 COPD, 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 5 inclusion and 5 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 13 Mar 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 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 Contré, Dr - Medical Director (+33147684121, c.contre@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of quality of life through CAT (COPD assessement tool) over 6 month period (time frame: Month 6). 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 13 Mar 2024.