Chronic Obstructive Pulmonary DiseaseTRISNOOZENCT04611633
Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE)
An observational study of Chronic Obstructive Pulmonary Disease, run by Chiesi SA/NV at 11 sites in Belgium.
Trial summary
This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general… 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?
- Trimbow
- How many people
- 14 participants
- Where
- 11 sitesBelgium
- Study dates
- 18 Jan 2021to 16 Sep 2021
- 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: The subject population will include adult patients aged 40 years or above diagnosed with COPD confirmed by spirometry (Tiffeneau index <0.7), who are stepping up from dual therapy (ICS/LABA or LABA/LAMA treatment at least 12 weeks prior to enrolment to the study) to a fixed triple maintenance therapy (Trimbow). Approximately 800 patients are expected to be enrolled at 200 GP practices in Belgium.
Who may be able to join
- Patient has provided written informed consent
- Patient is aged 40 years or older
- Current or ex-smokers with a smoking history ≥ 10 pack years
- Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index <0.7; baseline or older spirometry)
- Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study
- Patient is starting treatment with Trimbow® upon decision by their physician
Who cannot join
- Patients who are hypersensitive to one of the active substances or excipients
- Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment
- Patients on ICS, LABA or LAMA monotherapy
- Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening
- Patients participating simultaneously to other clinical trials or studies
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
General practitioners in the province of Antwerp
Antwerp, 2000
General practitioners in the province of Luxembourg
Arlon, Luxembourg, 6700
General practitioners in the province of West Flanders
Bruges, West Flanders, 8000
General practitioners in the province of East Flanders
Ghent, East Flanders, 9000
General practitioners in the province of Limburg
Hasselt, Limburg, 3500
General practitioners in the province of Flemish Brabant
Leuven, Flemish Brabant, 3000
General practitioners in the province of Liège
Liège, 4020
General practitioners in the province of Hainaut
Mons, Hainaut, 7000
CHU-UCL-Namur
Namur, 5000
General practitioners in the province of Namur
Namur, 5000
General practitioners in the province of Walloon Brabant
Wavre, Walloon Brabant, 1300
About this study
Official title: A Prospective Observational Study in COPD Patients Evaluating the Quality of Life in Patients Switching From a Dual Therapy to a Fixed LABA/LAMA/ICS Triple Therapy in Routine Practice
This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.
Read the detailed description
This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Trimbow
- 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.
TrimbowCombination product
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.
COPD symptoms
The patient's COPD symptoms at month 6 (visit 3), compared to baseline. This is measured by the COPD Assessment Test (CAT) questionnaire.
Measured: 6 months
Secondary outcomes (5)
COPD symptoms
The patient's COPD symptoms at month 3 (visit 2)
Measured: 3 months
Quality of sleep
The quality of sleep of the patients using the CASIS questionnaire at baseline, month 3 and 6 (visit 2 and 3)
Measured: 6 months
Treatment satisfaction
The patient's treatment satisfaction score using PGI-C at month 3 and 6 (visit 2 and 3)
Measured: 6 months
Rescue medication
Use of rescue medication at baseline and each follow-up visit (question on the past 7 days)
Measured: 6 months
Lung function parameters
Lung function parameters (FEV1, FVC) (if available) at baseline and each follow-up visit
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 posted2 Nov 2020
- Study start18 Jan 2021
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Why it stopped: Due to COVID pandemic not feasible to include patients for this study
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi SA/NV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Marchand, MD, PhD, Principal investigator, CHU Godinne UCL Namur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611633
- Sponsor's protocol ID
- CHIESI_NIS_004
- Acronym
- TRISNOOZE
- Status last verified
- Nov 2021
- First submitted
- 27 Oct 2020
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study in COPD Patients Evaluating the Quality of Life in Patients Switching From a Dual Therapy to a Fixed LABA/LAMA/ICS Triple Therapy in Routine Practice
- ClinicalTrials.gov ID
- NCT04611633
- Acronym / sponsor ID
- TRISNOOZE / CHIESI_NIS_004
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to COVID pandemic not feasible to include patients for this study
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chiesi SA/NVUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 2 Nov 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 non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.
Detailed description
This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.
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
- The subject population will include adult patients aged 40 years or above diagnosed with COPD confirmed by spirometry (Tiffeneau index <0.7), who are stepping up from dual therapy (ICS/LABA or LABA/LAMA treatment at least 12 weeks prior to enrolment to the study) to a fixed triple maintenance therapy (Trimbow). Approximately 800 patients are expected to be enrolled at 200 GP practices in Belgium.
Key inclusion criteria (6 listed)
- Patient has provided written informed consent
- Patient is aged 40 years or older
- Current or ex-smokers with a smoking history ≥ 10 pack years
- Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index <0.7; baseline or older spirometry)
- Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study
Key exclusion criteria (5 listed)
- Patients who are hypersensitive to one of the active substances or excipients
- Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment
- Patients on ICS, LABA or LAMA monotherapy
- Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening
- Patients participating simultaneously to other clinical trials or studies
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 |
|---|---|---|
| TrimbowAs 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. | Combination product | – |
Primary outcome
COPD symptoms
Time frame: 6 months
The patient's COPD symptoms at month 6 (visit 3), compared to baseline. This is measured by the COPD Assessment Test (CAT) questionnaire.
5 secondary outcomes
COPD symptoms
Time frame: 3 months
Quality of sleep
Time frame: 6 months
Treatment satisfaction
Time frame: 6 months
Rescue medication
Time frame: 6 months
Lung function parameters
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to COVID pandemic not feasible to include patients for this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
Eric Marchand, MD, PhD principal investigator
CHU Godinne UCL Namur
11 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 11 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 6 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: stopped early, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early (reason given: Due to COVID pandemic not feasible to include patients for this study). Results are not available in the source record.
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?
COPD symptoms (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 9 Dec 2021.