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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Combination product: Trimbow

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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • General practitioners in the province of Antwerp
  • Liège, Belgium, 4020
    • General practitioners in the province of Liège
  • Namur, Belgium, 5000
    • Chu-Ucl-Namur
  • Namur, Belgium, 5000
    • General practitioners in the province of Namur
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • General practitioners in the province of East Flanders
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium, 3000
      • General practitioners in the province of Flemish Brabant
  • Hainaut
    • Mons, Hainaut, Belgium, 7000
      • General practitioners in the province of Hainaut
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • General practitioners in the province of Limburg
  • Luxembourg
    • Arlon, Luxembourg, Belgium, 6700
      • General practitioners in the province of Luxembourg
  • Walloon Brabant
    • Wavre, Walloon Brabant, Belgium, 1300
      • General practitioners in the province of Walloon Brabant
  • West Flanders
    • Bruges, West Flanders, Belgium, 8000
      • General practitioners in the province of West Flanders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate/severe exacerbations	Number of moderate/severe exacerbations at baseline and at month 6	6 months

Collaborators and Investigators

• Sponsor: Chiesi SA/NV
• Investigators: Principal Investigator: Eric Marchand, MD, PhD, CHU Godinne UCL Namur

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): September 16, 2021
• Study Completion (Actual): September 16, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CHIESI_NIS_004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No