Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE)

NCT ID: NCT04611633

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2021-09-16

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi SA/NV

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Marchand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Godinne UCL Namur

Locations

General practitioners in the province of East Flanders

Ghent, East Flanders, Belgium

General practitioners in the province of Flemish Brabant

Leuven, Flemish Brabant, Belgium

General practitioners in the province of Hainaut

Mons, Hainaut, Belgium

General practitioners in the province of Limburg

Hasselt, Limburg, Belgium

General practitioners in the province of Luxembourg

Arlon, Luxembourg, Belgium

General practitioners in the province of Walloon Brabant

Wavre, Walloon Brabant, Belgium

General practitioners in the province of West Flanders

Bruges, West Flanders, Belgium

General practitioners in the province of Antwerp

Antwerp, , Belgium

General practitioners in the province of Liège

Liège, , Belgium

CHU-UCL-Namur

Namur, , Belgium

General practitioners in the province of Namur

Namur, , Belgium

Countries

Belgium

Other Identifiers

CHIESI_NIS_004

Identifier Type: -

Identifier Source: org_study_id