Loading clinical trials...

Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE) | Clinical Trials | Clareo Health

TERMINATED

Study in COPD Patients Evaluating the Quality of Life (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

NCT04611633•Chiesi SA/NV

View on ClinicalTrials.gov

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

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

January 18, 2021

Primary Completion Date

September 16, 2021

Completion Date

September 16, 2021

Last Updated

December 9, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Trimbow

COMBINATION_PRODUCT

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease