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

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04611633
• Lead Sponsor: Chiesi SA/NV

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.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2021-01-18
• Primary Completion: 2021-09-16
• Study Completion: 2021-09-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPD symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Rescue medication	6 months	Use of rescue medication at baseline and each follow-up visit (question on the past 7 days)
COPD symptoms	3 months	The patient's COPD symptoms at month 3 (visit 2)
Treatment satisfaction	6 months	The patient's treatment satisfaction score using PGI-C at month 3 and 6 (visit 2 and 3)
Quality of sleep	6 months	The quality of sleep of the patients using the CASIS questionnaire at baseline, month 3 and 6 (visit 2 and 3)
Lung function parameters	6 months	Lung function parameters (FEV1, FVC) (if available) at baseline and each follow-up visit

Trial Locations

Locations (11)

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

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