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

NCT04611633 | Terminated

• 1 other identifier: CHIESI_NIS_004
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• COPD symptoms

  3 months

• Quality of sleep

  6 months

• Treatment satisfaction

  6 months

• Rescue medication

  6 months

• Lung function parameters

  6 months

Other Outcomes (1)

• Moderate/severe exacerbations

  6 months

Interventions

Trimbow COMBINATION_PRODUCT

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi SA/NV: lead

Study Sites (11)

General practitioners in the province of East Flanders

Ghent, East Flanders, 9000, Belgium

Location

General practitioners in the province of Flemish Brabant

Leuven, Flemish Brabant, 3000, Belgium

Location

General practitioners in the province of Hainaut

Mons, Hainaut, 7000, Belgium

Location

General practitioners in the province of Limburg

Hasselt, Limburg, 3500, Belgium

Location

General practitioners in the province of Luxembourg

Arlon, Luxembourg, 6700, Belgium

Location

General practitioners in the province of Walloon Brabant

Wavre, Walloon Brabant, 1300, Belgium

Location

General practitioners in the province of West Flanders

Bruges, West Flanders, 8000, Belgium

Location

General practitioners in the province of Antwerp

Antwerp, 2000, Belgium

Location

General practitioners in the province of Liège

Liège, 4020, Belgium

Location

CHU-UCL-Namur

Namur, 5000, Belgium

Location

General practitioners in the province of Namur

Namur, 5000, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Marchand, MD, PhD

  CHU Godinne UCL Namur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: January 18, 2021
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

BE (11)