Chronic Obstructive Pulmonary DiseaseTRIVOLVENCT03627858
Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting
An observational study of Chronic Obstructive Pulmonary Disease, run by Chiesi SA/NV at 15 sites in Belgium.
Trial summary
The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- beclomethasone / formoterol / glycopyrronium
- How many people
- 149 participants
- Where
- 15 sitesBelgium
- Study dates
- 1 Aug 2018to 3 Aug 2020
- 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: Adult patients aged 40 years or above diagnosed with chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) who were prescribed Trimbow®
Who may be able to join
- Patient has provided written informed consent
- Patient is aged 40 years or older at time of initiation of Trimbow® treatment
- Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification
- Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®
Who cannot join
- Hypersensitivity to the active substances or to any of the excipients listed below:
- Ethanol anhydrous
- Hydrochloric acid
- Norflurane (propellant)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Belgium15 sites
ZNA Middelheim
Antwerp, 2020
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
GZA Campus Sint-Vincentius
Antwerp
Hôpital Erasme
Brussels
UZ Brussel
Brussels
Grand Hôpital de Charleroi
Charleroi, 6000
Clinique Notre-Dame de Grâce ASBL Gosselies
Charleroi
UZ Gent
Ghent
AZ Groeninge
Kortrijk
CHR de la Citadelle
Liège
AZ Sint-Maarten
Mechelen
Hôpital André Vésale
Montigny-le-Tilleul
Clinique Saint-Luc Bouge
Namur
AZ Delta
Roeselare
Hospital Center De Wallonie Picarde
Tournai
About this study
Official title: A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®
The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.
Read the detailed description
This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.
This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- beclomethasone / formoterol / glycopyrronium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone / formoterol / glycopyrroniumDrug
Also called Trimbow®
As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhalation technique score
Change in Inhalation Technique Score, measured as percentage of correct steps on the Inhalation Checklist (itemized instructions of inhaler correct use per respective Summaries of Product Characteristics) at each routine follow-up visit up to 6 months versus baseline.
This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
Measured: up to 6 months
Secondary outcomes (6)
Treatment adherence score
Degree of treatment adherence measured via the mean score on the Test of Adherence to Inhalers (TAI) questionnaire, including 5 questions completed by the patient (each item scored from 1 (worst) to 5 (best) with a range from 10 to 50) and 2 items completed by the physician (each item scored 1 (bad) or 2 (good) with a range from 2 to 4) at baseline and each routine follow-up visit up to 6 months versus baseline.
Measured: up to 6 months
Number of inhaled doses recorded by dose counter since previous visit
Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.
Measured: up to 6 months
Patient's treatment satisfaction score using visual analogue scale (0-10)
The patient's treatment satisfaction score measured on a visual analogue scale from 0 (worst) to 10 (best), at baseline and each routine follow-up visit.
Measured: up to 6 months
Number of rescue medication used within 7 days prior to each visit
The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.
Measured: up to 6 months
Patient's lung function as measured by spirometry
The pre and post bronchodilator forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) are measured at baseline and each routine follow-up visit.
Measured: up to 6 months
Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire
Patients complete the 8-item CAT questionnaire at baseline and each follow-up visit. Total scores range from 0 to 40 and higher scores indicate a worse health status.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Aug 2018
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi SA/NV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Brusselle, MD-PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627858
- Sponsor's protocol ID
- CHIESI_NIS_0001
- Acronym
- TRIVOLVE
- Status last verified
- Nov 2021
- First submitted
- 29 May 2018
- Last updated
- 29 Nov 2021
- 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 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®
- ClinicalTrials.gov ID
- NCT03627858
- Acronym / sponsor ID
- TRIVOLVE / CHIESI_NIS_0001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Chiesi SA/NVUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 14 Aug 2018 (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 rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.
Detailed description
This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.
This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
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
- Adult patients aged 40 years or above diagnosed with chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) who were prescribed Trimbow®
Key inclusion criteria (4 listed)
- Patient has provided written informed consent
- Patient is aged 40 years or older at time of initiation of Trimbow® treatment
- Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification
- Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®
Key exclusion criteria (4 listed)
- Hypersensitivity to the active substances or to any of the excipients listed below:
- Ethanol anhydrous
- Hydrochloric acid
- Norflurane (propellant)
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 |
|---|---|---|
| beclomethasone / formoterol / glycopyrroniumAlso: Trimbow®As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics. | Drug | – |
Primary outcome
Inhalation technique score
Time frame: up to 6 months
Change in Inhalation Technique Score, measured as percentage of correct steps on the Inhalation Checklist (itemized instructions of inhaler correct use per respective Summaries of Product Characteristics) at each routine follow-up visit up to 6 months versus baseline. This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
6 secondary outcomes
Treatment adherence score
Time frame: up to 6 months
Number of inhaled doses recorded by dose counter since previous visit
Time frame: up to 6 months
Patient's treatment satisfaction score using visual analogue scale (0-10)
Time frame: up to 6 months
Number of rescue medication used within 7 days prior to each visit
Time frame: up to 6 months
Patient's lung function as measured by spirometry
Time frame: up to 6 months
Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire
Time frame: up to 6 months
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 29 Nov 2021.
- 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.
Guy Brusselle, MD-PhD principal investigator
University Ghent
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Chiesi SA/NV at 15 sites in Belgium.
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 4 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 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium. 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?
Inhalation technique score (time frame: up to 6 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 29 Nov 2021.