COPDTriOptimizeNCT04355546
Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy
An observational study of COPD, run by Chiesi UK at 1 site in United Kingdom.
Trial summary
This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- Non-interventional
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2020to 9 Jun 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 35 to 100 years
- 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, or, if incapable of doing so, after such consent has been provided by a legally acceptable representative of the patient.
Who may be able to join
- Patients with moderate to severe COPD (with and without concomitant asthma)
- Physician decision to start therapy with Trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this Non-Interventional Trial
- Patients with at least one COPD exacerbation within the previous 12 months
- Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial
Who cannot join
- Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment
- Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Foundation Trust
Liverpool, L14 3PE
About this study
Official title: A Prospective Non-interventional Trial on COPD Patients' Health Related Quality of Life Under a Fixed LAMA/LABA/ICS Triple Therapy and Characterization of Determinants of Treatment Adherence
This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence.
Read the detailed description
The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers.
The effects of Trimbow® on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow® as per the authorised indication. We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow® as used in everyday routine.
- Conditions
- COPD
- Being tested
- Non-interventional
- 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.
Non-interventionalOther
As this is a Non-interventional trial, only data obtained within the current routine management of COPD at outpatient respiratory centres or GP centres will be documented.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Trimbow 87/5/9 pMDI for COPD prescribed according to licensed indication Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in health related quality of life in COPD patients prescribed Trimbow
Change in total CAT score between baseline and after 6 months of treatment.
Measured: 6 months
Secondary outcomes (4)
Assess adherence to COPD therapy
changes in adherence scores (assessed by means of TAI questionnaire),
Measured: 6 months
changes in relevant spirometry parameters
between baseline, e.g. FEV1, FVC
Measured: 6 months
incidence of clinical events
e.g. exacerbations
Measured: 6 months
Compare requirement of rescue medication and alteration of COPD therapy
incidence of COPD medication changes and rescue medication use medication changes and rescue medication use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start15 Jul 2020
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355546
- Sponsor's protocol ID
- NIS 004 Pn
- Acronym
- TriOptimize
- Status last verified
- Aug 2023
- First submitted
- 20 Apr 2020
- Last updated
- 2 Aug 2023
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Trial on COPD Patients' Health Related Quality of Life Under a Fixed LAMA/LABA/ICS Triple Therapy and Characterization of Determinants of Treatment Adherence
- ClinicalTrials.gov ID
- NCT04355546
- Acronym / sponsor ID
- TriOptimize / NIS 004 Pn
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chiesi UKIndustry (pharma, biotech, devices)
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 21 Apr 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.
This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence.
Detailed description
The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers.
The effects of Trimbow® on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow® as per the authorised indication. We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow® as used in everyday routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: Non-interventionalTrimbow 87/5/9 pMDI for COPD prescribed according to licensed indication |
Who may qualify
- Ages
- 35 to 100 years
- 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, or, if incapable of doing so, after such consent has been provided by a legally acceptable representative of the patient.
Key inclusion criteria (4 listed)
- Patients with moderate to severe COPD (with and without concomitant asthma)
- Physician decision to start therapy with Trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this Non-Interventional Trial
- Patients with at least one COPD exacerbation within the previous 12 months
- Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial
Key exclusion criteria (2 listed)
- Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment
- Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial
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 COPD at outpatient respiratory centres or GP centres will be documented. | Other | COPD patients |
Primary outcome
Assess change in health related quality of life in COPD patients prescribed Trimbow
Time frame: 6 months
Change in total CAT score between baseline and after 6 months of treatment.
4 secondary outcomes
Assess adherence to COPD therapy
Time frame: 6 months
changes in relevant spirometry parameters
Time frame: 6 months
incidence of clinical events
Time frame: 6 months
Compare requirement of rescue medication and alteration of COPD therapy
Time frame: 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 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 UK at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 2 Aug 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 United Kingdom. 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?
Assess change in health related quality of life in COPD patients prescribed Trimbow (time frame: 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 2 Aug 2023.