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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04611633
• Other study ID #: CHIESI_NIS_004
• Status: Terminated
• Start date: January 18, 2021
• Est. completion date: September 16, 2021

Study information

• Verified date: November 2021
• Source: Chiesi SA/NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 practitioner setting.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 16, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Belgium	General practitioners in the province of Antwerp	Antwerp
Belgium	General practitioners in the province of Luxembourg	Arlon	Luxembourg
Belgium	General practitioners in the province of West Flanders	Bruges	West Flanders
Belgium	General practitioners in the province of East Flanders	Ghent	East Flanders
Belgium	General practitioners in the province of Limburg	Hasselt	Limburg
Belgium	General practitioners in the province of Flemish Brabant	Leuven	Flemish Brabant
Belgium	General practitioners in the province of Liège	Liège
Belgium	General practitioners in the province of Hainaut	Mons	Hainaut
Belgium	CHU-UCL-Namur	Namur
Belgium	General practitioners in the province of Namur	Namur
Belgium	General practitioners in the province of Walloon Brabant	Wavre	Walloon Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi SA/NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderate/severe exacerbations	Number of moderate/severe exacerbations at baseline and at month 6	6 months
Primary	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	COPD symptoms	The patient's COPD symptoms at month 3 (visit 2)	3 months
Secondary	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
Secondary	Treatment satisfaction	The patient's treatment satisfaction score using PGI-C at month 3 and 6 (visit 2 and 3)	6 months
Secondary	Rescue medication	Use of rescue medication at baseline and each follow-up visit (question on the past 7 days)	6 months
Secondary	Lung function parameters	Lung function parameters (FEV1, FVC) (if available) at baseline and each follow-up visit	6 months