Clinical trial NCT04611633: Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE)
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chiesi SA/NV
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: COPD symptoms
timeFrame: 6 months
Secondary outcomes:
measure: COPD symptoms
timeFrame: 3 months
measure: Quality of sleep
timeFrame: 6 months
measure: Treatment satisfaction
timeFrame: 6 months
measure: Rescue medication
timeFrame: 6 months
measure: Lung function parameters
timeFrame: 6 months
Other outcomes:
measure: Moderate/severe exacerbations
timeFrame: 6 months
Locations:
city: Ghent
country: Belgium
facility: General practitioners in the province of East Flanders
state: East Flanders
city: Leuven
country: Belgium
facility: General practitioners in the province of Flemish Brabant
state: Flemish Brabant
city: Mons
country: Belgium
facility: General practitioners in the province of Hainaut
state: Hainaut
city: Hasselt
country: Belgium
facility: General practitioners in the province of Limburg
state: Limburg
city: Arlon
country: Belgium
facility: General practitioners in the province of Luxembourg
state: Luxembourg
city: Wavre
country: Belgium
facility: General practitioners in the province of Walloon Brabant
state: Walloon Brabant
city: Bruges
country: Belgium
facility: General practitioners in the province of West Flanders
state: West Flanders
city: Antwerp
country: Belgium
facility: General practitioners in the province of Antwerp
city: Liège
country: Belgium
facility: General practitioners in the province of Liège
city: Namur
country: Belgium
facility: CHU-UCL-Namur
city: Namur
country: Belgium
facility: General practitioners in the province of Namur
Study officials:
affiliation: CHU Godinne UCL Namur
name: Eric Marchand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: